xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038097</url>
    </required_header>
    <id_info>
      <org_study_id>IEC-465/03.08.2023</org_study_id>
      <nct_id>NCT06038097</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia</brief_title>
    <official_title>Efficacy and Safety of Radiofrequency Pallidotomy in the Management of Dystonia - A Delayed Start Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>All India Institute of Medical Sciences, New Delhi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>All India Institute of Medical Sciences, New Delhi</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Generalized dystonia is treated with pallidotomy. This is based on observational data which&#xD;
        is significantly limited by publication bias and there are no RCTs. The case reports focus on&#xD;
        successful outcomes and case series have an inherent selection bias. Bilateral pallidotomy&#xD;
        has been used in our institute in a series of patients with generalized and segmental&#xD;
        dystonia and have been seen to show good efficacy. However, the existing literature suggests&#xD;
        that it is also associated with dysphagia and dysarthria in some cases and thus simultaneous&#xD;
        bilateral pallidotomy is not preferred in several centres. However, our center routinely&#xD;
        performs simultaneous bilateral pallidotomy.&#xD;
  &#xD;
        The response rates and compliations of the procedure have not been systematically studied in&#xD;
        RCT and we need to generate data on the efficacy and safety of Pallidotomy on generalized and&#xD;
        segmental dystonia. This randomized controlled trial will fill the void in knowledge in this&#xD;
        field.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Deep brain stimulation surgery (DBS) has become the standard of care for the management of&#xD;
        generalized dystonia It has been shown in Randomized controlled trials to be effective and&#xD;
        safe.1-3 Since the last 30 years, DBS has been used to treat a variety of patients with&#xD;
        dystonias, which are of varying etiologies. However, the DBS is an expensive system, needs&#xD;
        hardware implantation and regular programming. It is associated with surgical implantation&#xD;
        which may lead to complications such as infection of the hardware, leads and electrodes.&#xD;
        Since it is expensive, it is out of reach for the majority of the patients who pay out of&#xD;
        pocket. It leads to increased healthcare costs because of the initial expenses for the&#xD;
        implant as well as regular follow ups for programming. The programming is currently labour&#xD;
        intensive and needs long hours of observation with trial and error to find the optimum&#xD;
        programming settings for the individual patient. This may need the patient to be admitted in&#xD;
        the inpatient setting or multiple outpatient visits for the patient, which can lead to loss&#xD;
        of working hours and burden on the healthcare system. Before the introduction of DBS by&#xD;
        Benabid, functional neurosurgery with lesioning procedures such as pallidotomy, thalamotomy,&#xD;
        subthalamotomy were used to manage movement disorders such as dystonia, tremors and Parkinson&#xD;
        disease. However after the advent of DBS, these procedures have taken a backseat. Also there&#xD;
        are no randomized trials for the safety and efficacy of lesioning procedures in dystonias.&#xD;
        The current practice in various centers of the world is to do unilateral pallidotomy in most&#xD;
        cases of dystonia. Simultaneous bilateral pallidotomy is not preferred by several&#xD;
        practitioners due to the risk of bulbar symptoms which may be irreversible in certain cases.&#xD;
        However, our experience in our Institute suggests good outcomes in patients with various&#xD;
        forms of focal and generalized dystonias undergoing simultaneous bilateral pallidotomy using&#xD;
        radiofrequency ablation. Similarly we have done pallidotomy for genetic dystonias such as&#xD;
        NBIAs, Wilson's disease who had disabling dystonias or medically refractory status&#xD;
        dystonicus.4 However, the long term efficacy and safety of these patients is not clear as&#xD;
        there are no registries or long term follow up data. We need a well conducted Randomized&#xD;
        controlled trial to systematically collect data on the efficacy and safety of the&#xD;
        intervention to generate meaningful information for patients and clinicians to understand the&#xD;
        risks and benefits of the procedures and offer relevant information for clinical decision&#xD;
        making.&#xD;
  &#xD;
        Problem statement Evidence based management requires robust data to make clinical decisions.&#xD;
        This data is derived from studies which may be observational or interventional. In the&#xD;
        evidence pyramid, meta-analysis of randomized controlled trials is considered to be of the&#xD;
        highest quality of evidence.&#xD;
  &#xD;
        Generalized dystonia is treated with pallidotomy. This is based on observational data which&#xD;
        is significantly limited by publication bias and there are no RCTs. The case reports focus on&#xD;
        successful outcomes and case series have an inherent selection bias. Bilateral pallidotomy&#xD;
        has been used in our institute in a series of patients with generalized and segmental&#xD;
        dystonia and have been seen to show good efficacy. However, the existing literature suggests&#xD;
        that it is also associated with dysphagia and dysarthria in some cases and thus simultaneous&#xD;
        bilateral pallidotomy is not preferred in several centres. However, our center routinely&#xD;
        performs simultaneous bilateral pallidotomy.&#xD;
  &#xD;
        The response rates and compliations of the procedure have not been systematically studied in&#xD;
        RCT and we need to generate data on the efficacy and safety of Pallidotomy on generalized and&#xD;
        segmental dystonia. This randomized controlled trial will fill the void in knowledge in this&#xD;
        field.&#xD;
  &#xD;
        Review of literature There are no randomized controlled trials to study the efficacy and&#xD;
        safety of pallidotomy or thalamotomy in the management of dystonia. The case series and case&#xD;
        reports regarding pallidotomy in dystonia describe a heterogenous population of patients who&#xD;
        had undergone the procedure.5-10 Most of the case series have a bias towards reporting&#xD;
        favourable outcomes. We found a meta-analysis of 100 patients who underwent bilateral&#xD;
        procedures for dystonia.11 This meta-analysis described 33 studies with varying indications&#xD;
        such as generalized dystonia, dystonic storm and focal dystonias. The majority of the&#xD;
        patients had genetic causes of dystonia with DYT1 being the most common known genetic cause.&#xD;
        Some studies reported a staged bilateral procedures while some simultaneous bilateral&#xD;
        pallidotomy. The median time of follow up was 12 months with a range of 2-180 months. This&#xD;
        meta-analysis revealed that 8% patients had transient adverse effects while 11% had permanent&#xD;
        adverse effects. The commonest adverse effects that were permanent involved bulbar&#xD;
        dysfunction with dysarthria anarthria or mutism. Most of the patients had a lasting&#xD;
        beneficial effect while 19% patients had relapse of symptoms on prolonged follow up. The time&#xD;
        to relapse of symptoms ranged from 3 weeks to 4.5 years. The predictors of response or&#xD;
        relapse were not apparent from this meta-analysis. Moreover, why pallidotomy was preferred in&#xD;
        contrast to DBS is not clear from the reports. Another case series describing 89 patients who&#xD;
        underwent radiofrequency pallidotomy suggested unacceptable rates of complications with&#xD;
        bilateral pallidotomy such as medically refractory parkinsonism, dysarthria and dysphagia.12&#xD;
        However these are retrospective review of data and the adverse effects may have been&#xD;
        selectively reported in both unilateral and bilateral cases. In our center 10 children&#xD;
        underwent bilateral simultaneous pallidotomy over a 7 year period and it was found that two&#xD;
        patients had undergone the procedure for medically refractory status dystonicus and both of&#xD;
        them had resolution of the status dystonicus. Two patients with generalized dystonia had&#xD;
        recurrence of symptoms over a follow up of 4.5 years while three had a sustained improvement&#xD;
        of more than 40% improvement in BFMDRS.4&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>BFM Dystonia disability scale</measure>
      <time_frame>6 weeks</time_frame>
      <description>To compare the BFM Dystonia disability scale 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the BFM Dystonia disability scale 6 weeks following acceptance of the procedure in those who were randomized to undergo the procedure atleast 12 weeks after accepting the the procedure (delayed treatment arm)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse effects: New onset or worsening Dysphagia or dysarthria</measure>
      <time_frame>12 weeks</time_frame>
      <description>To study the incidence of new onset or worsening dysphagia or dysarthria in patients with dystonia undergoing bilateral simultaneous pallidotomy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>20% improvement in BFM Dystonia disability scale</measure>
      <time_frame>6 weeks</time_frame>
      <description>To compare the proportion of patients having atleast 20% improvement in BFM Dystonia disability scale from baseline to 6 weeks following bilateral simultaneous radiofrequency pallidotomy(early treatment arm) with the proportion of patients with similar improvement from baseline to 6 weeks following acceptance of procedure in those who undergo surgery atleast 12 weeks after accepting the procedure (delayed treatment arm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>20% improvement in BFM Dystonia movement scale</measure>
      <time_frame>6 weeks</time_frame>
      <description>To compare the proportion of patients having atleast 20% improvement in BFM Dystonia movement scale from baseline to 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the proportion of patients with similar improvement from baseline to 6 weeks following acceptance of procedure in those who undergo surgery atleast 3 months after accepting the procedure (delayed treatment arm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse effects</measure>
      <time_frame>12 weeks</time_frame>
      <description>To study the proportion of patients in early and delayed treatment arm who develop adverse effects during the 12 weeks following surgery or agreeing for surgery respectively.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Dystonia</condition>
    <arm_group>
      <arm_group_label>Early intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Radiofrequency Pallidotomy at earliest available date</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delayed intervention arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Radiofrequency pallidotomy offered at 12 weeks following agreeing to participate in the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Radiofrequency Pallidotomy</intervention_name>
      <description>Radiofrequency bilateral simultaneous pallidotomy</description>
      <arm_group_label>Early intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with generalized, segmental or focal dystonias who are being considered for&#xD;
               simultaneous bilateral radiofrequency pallidotomy.&#xD;
  &#xD;
            2. Of all ages and gender&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those who deny consent&#xD;
  &#xD;
            2. Pregnant ladies and women of childbearing potential without adequate contraception&#xD;
  &#xD;
            3. Those who have undergone botulinum toxin injection in the last 12 weeks or those who&#xD;
               are being planned for the same in the upcoming 12 weeks.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arunmozhimaran Elavarasi, MD DM</last_name>
      <role>Principal Investigator</role>
      <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Arunmozhimaran Elavarasi, MD DM</last_name>
      <phone>+919013844274</phone>
      <email>arun_ela@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Padma Srivastava MV, MD DM</last_name>
      <phone>+919868398261</phone>
      <email>vasanthapadma123@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>All India Institute of Medical Sciences, New Delhi</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110029</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
      <investigator_full_name>Arunmozhimaran Elavarasi</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Dystonia</keyword>
    <keyword>Segmental dystonia</keyword>
    <keyword>Generalized dystonia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dystonia</mesh_term>
      <mesh_term>Dystonic Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified patient data will be shared on approaching through proper channel through ethics committee AIIMS, New Delhi</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Will become available after the project is completed, will be available for 5 years atleast after completition of the trial</ipd_time_frame>
      <ipd_access_criteria>De-identified patient data will be shared on approaching through proper channel through ethics committee AIIMS, New Delhi</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038097
  org study id: IEC-465/03.08.2023
  nct id: NCT06038097
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Generalized dystonia is treated with pallidotomy. This is based on observational data which
        is significantly limited by publication bias and there are no RCTs. The case reports focus on
        successful outcomes and case series have an inherent selection bias. Bilateral pallidotomy
        has been used in our institute in a series of patients with generalized and segmental
        dystonia and have been seen to show good efficacy. However, the existing literature suggests
        that it is also associated with dysphagia and dysarthria in some cases and thus simultaneous
        bilateral pallidotomy is not preferred in several centres. However, our center routinely
        performs simultaneous bilateral pallidotomy.
  
        The response rates and compliations of the procedure have not been systematically studied in
        RCT and we need to generate data on the efficacy and safety of Pallidotomy on generalized and
        segmental dystonia. This randomized controlled trial will fill the void in knowledge in this
        field.
  Deep brain stimulation surgery (DBS) has become the standard of care for the management of
        generalized dystonia It has been shown in Randomized controlled trials to be effective and
        safe.1-3 Since the last 30 years, DBS has been used to treat a variety of patients with
        dystonias, which are of varying etiologies. However, the DBS is an expensive system, needs
        hardware implantation and regular programming. It is associated with surgical implantation
        which may lead to complications such as infection of the hardware, leads and electrodes.
        Since it is expensive, it is out of reach for the majority of the patients who pay out of
        pocket. It leads to increased healthcare costs because of the initial expenses for the
        implant as well as regular follow ups for programming. The programming is currently labour
        intensive and needs long hours of observation with trial and error to find the optimum
        programming settings for the individual patient. This may need the patient to be admitted in
        the inpatient setting or multiple outpatient visits for the patient, which can lead to loss
        of working hours and burden on the healthcare system. Before the introduction of DBS by
        Benabid, functional neurosurgery with lesioning procedures such as pallidotomy, thalamotomy,
        subthalamotomy were used to manage movement disorders such as dystonia, tremors and Parkinson
        disease. However after the advent of DBS, these procedures have taken a backseat. Also there
        are no randomized trials for the safety and efficacy of lesioning procedures in dystonias.
        The current practice in various centers of the world is to do unilateral pallidotomy in most
        cases of dystonia. Simultaneous bilateral pallidotomy is not preferred by several
        practitioners due to the risk of bulbar symptoms which may be irreversible in certain cases.
        However, our experience in our Institute suggests good outcomes in patients with various
        forms of focal and generalized dystonias undergoing simultaneous bilateral pallidotomy using
        radiofrequency ablation. Similarly we have done pallidotomy for genetic dystonias such as
        NBIAs, Wilson's disease who had disabling dystonias or medically refractory status
        dystonicus.4 However, the long term efficacy and safety of these patients is not clear as
        there are no registries or long term follow up data. We need a well conducted Randomized
        controlled trial to systematically collect data on the efficacy and safety of the
        intervention to generate meaningful information for patients and clinicians to understand the
        risks and benefits of the procedures and offer relevant information for clinical decision
        making.
  
        Problem statement Evidence based management requires robust data to make clinical decisions.
        This data is derived from studies which may be observational or interventional. In the
        evidence pyramid, meta-analysis of randomized controlled trials is considered to be of the
        highest quality of evidence.
  
        Generalized dystonia is treated with pallidotomy. This is based on observational data which
        is significantly limited by publication bias and there are no RCTs. The case reports focus on
        successful outcomes and case series have an inherent selection bias. Bilateral pallidotomy
        has been used in our institute in a series of patients with generalized and segmental
        dystonia and have been seen to show good efficacy. However, the existing literature suggests
        that it is also associated with dysphagia and dysarthria in some cases and thus simultaneous
        bilateral pallidotomy is not preferred in several centres. However, our center routinely
        performs simultaneous bilateral pallidotomy.
  
        The response rates and compliations of the procedure have not been systematically studied in
        RCT and we need to generate data on the efficacy and safety of Pallidotomy on generalized and
        segmental dystonia. This randomized controlled trial will fill the void in knowledge in this
        field.
  
        Review of literature There are no randomized controlled trials to study the efficacy and
        safety of pallidotomy or thalamotomy in the management of dystonia. The case series and case
        reports regarding pallidotomy in dystonia describe a heterogenous population of patients who
        had undergone the procedure.5-10 Most of the case series have a bias towards reporting
        favourable outcomes. We found a meta-analysis of 100 patients who underwent bilateral
        procedures for dystonia.11 This meta-analysis described 33 studies with varying indications
        such as generalized dystonia, dystonic storm and focal dystonias. The majority of the
        patients had genetic causes of dystonia with DYT1 being the most common known genetic cause.
        Some studies reported a staged bilateral procedures while some simultaneous bilateral
        pallidotomy. The median time of follow up was 12 months with a range of 2-180 months. This
        meta-analysis revealed that 8% patients had transient adverse effects while 11% had permanent
        adverse effects. The commonest adverse effects that were permanent involved bulbar
        dysfunction with dysarthria anarthria or mutism. Most of the patients had a lasting
        beneficial effect while 19% patients had relapse of symptoms on prolonged follow up. The time
        to relapse of symptoms ranged from 3 weeks to 4.5 years. The predictors of response or
        relapse were not apparent from this meta-analysis. Moreover, why pallidotomy was preferred in
        contrast to DBS is not clear from the reports. Another case series describing 89 patients who
        underwent radiofrequency pallidotomy suggested unacceptable rates of complications with
        bilateral pallidotomy such as medically refractory parkinsonism, dysarthria and dysphagia.12
        However these are retrospective review of data and the adverse effects may have been
        selectively reported in both unilateral and bilateral cases. In our center 10 children
        underwent bilateral simultaneous pallidotomy over a 7 year period and it was found that two
        patients had undergone the procedure for medically refractory status dystonicus and both of
        them had resolution of the status dystonicus. Two patients with generalized dystonia had
        recurrence of symptoms over a follow up of 4.5 years while three had a sustained improvement
        of more than 40% improvement in BFMDRS.4
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: BFM Dystonia disability scale
  time frame: 6 weeks
  description: To compare the BFM Dystonia disability scale 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the BFM Dystonia disability scale 6 weeks following acceptance of the procedure in those who were randomized to undergo the procedure atleast 12 weeks after accepting the the procedure (delayed treatment arm)
  measure: Adverse effects: New onset or worsening Dysphagia or dysarthria
  time frame: 12 weeks
  description: To study the incidence of new onset or worsening dysphagia or dysarthria in patients with dystonia undergoing bilateral simultaneous pallidotomy
  measure: 20% improvement in BFM Dystonia disability scale
  time frame: 6 weeks
  description: To compare the proportion of patients having atleast 20% improvement in BFM Dystonia disability scale from baseline to 6 weeks following bilateral simultaneous radiofrequency pallidotomy(early treatment arm) with the proportion of patients with similar improvement from baseline to 6 weeks following acceptance of procedure in those who undergo surgery atleast 12 weeks after accepting the procedure (delayed treatment arm)
  measure: 20% improvement in BFM Dystonia movement scale
  time frame: 6 weeks
  description: To compare the proportion of patients having atleast 20% improvement in BFM Dystonia movement scale from baseline to 6 weeks following bilateral simultaneous radiofrequency pallidotomy (early treatment arm) with the proportion of patients with similar improvement from baseline to 6 weeks following acceptance of procedure in those who undergo surgery atleast 3 months after accepting the procedure (delayed treatment arm)
  measure: Adverse effects
  time frame: 12 weeks
  description: To study the proportion of patients in early and delayed treatment arm who develop adverse effects during the 12 weeks following surgery or agreeing for surgery respectively.
  arm group label: Early intervention arm
  arm group type: Experimental
  description: Radiofrequency Pallidotomy at earliest available date
  arm group label: Delayed intervention arm
  arm group type: No Intervention
  description: Radiofrequency pallidotomy offered at 12 weeks following agreeing to participate in the study
  intervention type: Procedure
  intervention name: Radiofrequency Pallidotomy
  description: Radiofrequency bilateral simultaneous pallidotomy
  arm group label: Early intervention arm
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Arunmozhimaran Elavarasi, MD DM
  role: Principal Investigator
  affiliation: All India Institute of Medical Sciences, New Delhi
  last name: Arunmozhimaran Elavarasi, MD DM
  phone: +919013844274
  email: arun_ela@yahoo.com
  last name: Padma Srivastava MV, MD DM
  phone: +919868398261
  email: vasanthapadma123@gmail.com
  facility: 
  country: India
  responsible party type: Principal Investigator
  investigator affiliation: All India Institute of Medical Sciences, New Delhi
  investigator full name: Arunmozhimaran Elavarasi
  investigator title: Assistant Professor
  mesh term: Dystonia
  mesh term: Dystonic Disorders
  sharing ipd: Yes
  ipd description: De-identified patient data will be shared on approaching through proper channel through ethics committee AIIMS, New Delhi
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Will become available after the project is completed, will be available for 5 years atleast after completition of the trial
  ipd access criteria: De-identified patient data will be shared on approaching through proper channel through ethics committee AIIMS, New Delhi