<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/NCT03229642</url>
  </required_header>
  <id_info>
    <org_study_id>B-BR-105-094</org_study_id>
    <nct_id>NCT03229642</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use Disorders</brief_title>
  <official_title>The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Opioid Use Disorders: Analysis of Clinical Outcomes, Functional Magnetic Resonance Imaging, Biomarkers, and Neuropsychological Tests</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens.&#xD;
      Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD,&#xD;
      high drop-out rate and the requirement of continuing use of opioid agonists are the major&#xD;
      problems. Therefore, to develop novel treatment for OUD is important.&#xD;
&#xD;
      Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain&#xD;
      stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that&#xD;
      there may be potential therapeutic effects in rTMS for addictive disorder, including reducing&#xD;
      craving and substance use severity. The underlying mechanisms of rTMS in treating addictions&#xD;
      may involve increased dopamine function in corticomesolimbic brain circuits and modulation of&#xD;
      neural activity in brain circuits that relevant to addiction. However, the treatment results&#xD;
      of rTMS in OUD were lacked, and the analysis in functional brain imaging study,&#xD;
      neuropsychological tests and other potential biomarkers under rTMS treatment were limited,&#xD;
      too.&#xD;
&#xD;
      Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS&#xD;
      treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be&#xD;
      allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the&#xD;
      left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train,&#xD;
      inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The&#xD;
      treatment response, urine drug tests, craving scales and side effects to evaluate the&#xD;
      therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional&#xD;
      magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters&#xD;
      will also be measured during 12-weeks follow up. The study results will provide the important&#xD;
      data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2)&#xD;
      reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with&#xD;
      improvement in fMRI, biological markers and psychological tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The treatment retention rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the treatment retention rate between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The treatment attendance rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the treatment attendance rate between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>Urinary morphine examinations will be measured at every visit. The rate of positive urinary morphine tests will be compared between active and sham rTMS groups in 12 weeks of follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fMRI</measure>
    <time_frame>5 weeks</time_frame>
    <description>The fMRI scan will be done at initial screen and at week 5 (after rTMS treatment) with resting-state fMRI and task activation fMRI with an IGT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological markers</measure>
    <time_frame>12 weeks</time_frame>
    <description>Twenty milliliters of blood will be drawn from each participant. Plasma will be isolated from the whole blood after it has been centrifuged at 3000 g for 15 min at 4℃, and the will be immediately stored at -80℃. Cytokine and BDNF levels will be quantified using an antibody pair assay system (Flexia; BioSource Intl., Camarillo, CA). Sample processing and data analysis will be done according to the manufacturer's instructions.&#xD;
The immunological parameters that we intend to analyze will include TNF-α, CRP, TGF-β1, IL-8, Il-10 and BDNF. The immunological markers will be measured from baseline to endpoint (week 12) in each patient group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Memory Scale - third edition(WMS-III)</measure>
    <time_frame>12 weeks</time_frame>
    <description>WMS-III will be tested at initial screen and at the end of study (week 12) and compared between the active and sham rTMS groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wisconsin Card Sorting Test(WCST)</measure>
    <time_frame>12 weeks</time_frame>
    <description>WCST will be tested at initial screen and at the end of study (week 12) and compared between the active and sham rTMS groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous performance tests(CPT)</measure>
    <time_frame>12 weeks</time_frame>
    <description>CPT will be tested at initial screen and at the end of study (week 12) and compared between the active and sham rTMS groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effect checklist</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the side effect profiles using side effect checklist between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of craving</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the severity of craving between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>17-item Hamilton Depression Rating Scale (HDRS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the mood symptoms between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization's Quality of Life Assessment-Brief of Taiwan (WHOQOL-BREF TW)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the life quality (using WHOQOL-BREF TW) between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family APGAR index</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the level of family support (using family APGAR index) between the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Opiate Treatment Index (OTI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the OTI tween the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions (CGI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the CGI tween the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barratt Impulsiveness Scale(BIS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To compare the BIS tween the active and sham rTMS groups from baseline to endpoint (12 weeks).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Transcranial Magnetic Stimulation</condition>
  <condition>Heroin Dependence</condition>
  <arm_group>
    <arm_group_label>Active rTMS treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The rTMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham rTMS treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The rTMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min, with a figure-of-eight sham coil. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active rTMS</intervention_name>
    <description>The stimulator device was a Magstim super rapid magnetic stimulator (Magstim Company, Ltd., Wales, United Kingdom) with 4 booster modules equipped with a 70-mm air-cooled figure-eight-shaped coil. We performed rTMS on the left dorsolateral prefrontal cortex (DLPFC).The TMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.</description>
    <arm_group_label>Active rTMS treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham rTMS</intervention_name>
    <description>The stimulator device was a Magstim super rapid magnetic stimulator (Magstim Company, Ltd., Wales, United Kingdom) with 4 booster modules equipped with a 70-mm air-cooled figure-eight-shaped coil. We performed rTMS on the left dorsolateral prefrontal cortex (DLPFC).The TMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.</description>
    <arm_group_label>Sham rTMS treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent by patient or legal representative.&#xD;
&#xD;
          2. Male or female patient aged ≧20 and ≦65 years.&#xD;
&#xD;
          3. A diagnosis of OUD according to DSM criteria made by a specialist in psychiatry.&#xD;
&#xD;
          4. Patient or a reliable caregiver can be expected to ensure acceptable compliance and&#xD;
             visit attendance for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women of childbearing potential, not using adequate contraception as per investigator&#xD;
             judgment or not willing to comply with contraception for the duration of the study.&#xD;
&#xD;
          2. Females who are pregnant or lactation.&#xD;
&#xD;
          3. Current evidence of an uncontrolled and/or clinically significant medical condition,&#xD;
             e.g.,cardiac, hepatic and renal failure that would compromise patient safety or&#xD;
             preclude study participation.&#xD;
&#xD;
          4. History of seizure or epilepsy.&#xD;
&#xD;
          5. History of neurological diseases or traumatic brain injury.&#xD;
&#xD;
          6. Suicidal attempts or risks during screen or study period.&#xD;
&#xD;
          7. Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators,&#xD;
             magnetic cochlear prosthesis, intraocular metallic fragments.&#xD;
&#xD;
          8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first&#xD;
             intervention of the double-blinded treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tzu-Yun Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cheng-Kung University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tzu-Yun Wang</last_name>
    <phone>+886-6-2353535</phone>
    <phone_ext>5940</phone_ext>
    <email>tzuyun0105@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tzu-Yun Wang</last_name>
      <phone>+886-6-235-3535</phone>
      <phone_ext>4200</phone_ext>
      <email>tzuyun0105@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Tzu-Yun Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>September 13, 2020</last_update_submitted>
  <last_update_submitted_qc>September 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Tzu-Yun Wang</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>repetitive transcranial magnetic stimulation</keyword>
  <keyword>opioid use disorder</keyword>
  <keyword>craving</keyword>
  <keyword>functional magnetic resonance imaging</keyword>
  <keyword>neuropsychological tests</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Heroin Dependence</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03229642
org study id: B-BR-105-094
nct id: NCT03229642
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Opioid use disorder (OUD) is prevalent and causes substantial health and social burdens.
      Although evidence have showed the effectiveness of opioid agonist maintenance therapy in OUD,
      high drop-out rate and the requirement of continuing use of opioid agonists are the major
      problems. Therefore, to develop novel treatment for OUD is important.

      Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method of brain
      stimulation used to treat a variety of neuropsychiatric disorders. Recent studies showed that
      there may be potential therapeutic effects in rTMS for addictive disorder, including reducing
      craving and substance use severity. The underlying mechanisms of rTMS in treating addictions
      may involve increased dopamine function in corticomesolimbic brain circuits and modulation of
      neural activity in brain circuits that relevant to addiction. However, the treatment results
      of rTMS in OUD were lacked, and the analysis in functional brain imaging study,
      neuropsychological tests and other potential biomarkers under rTMS treatment were limited,
      too.

      Thus, the investigators will conduct the add-on double-blinded, sham-controlled study rTMS
      treatment in 40-60 patients with OUD under methadone maintenance therapy. Patients will be
      allocated to active and sham rTMS in a 1 : 1 ratio, and participants will receive rTMS on the
      left dorsolateral prefrontal cortex (DLPFC) (15 Hz frequency, 4 seconds per train,
      inter-train interval of 26 seconds, 40 trains per session, total 11 sessions in 4 weeks). The
      treatment response, urine drug tests, craving scales and side effects to evaluate the
      therapeutic effects of rTMS will be examined. Neuropsychological assessments, functional
      magnetic resonance imaging (fMRI) and tests for potential biomarkers of immune parameters
      will also be measured during 12-weeks follow up. The study results will provide the important
      data in whether rTMS add-on methadone maintenance therapy is able to 1) reduce heroin use; 2)
      reduce craving for heroin; 3) be an effective treatment for OUD, and 4) be associated with
      improvement in fMRI, biological markers and psychological tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The treatment retention rate
time frame: 12 weeks
description: To compare the treatment retention rate between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: The treatment attendance rate
time frame: 12 weeks
description: To compare the treatment attendance rate between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: Urinary assessment
time frame: 12 weeks
description: Urinary morphine examinations will be measured at every visit. The rate of positive urinary morphine tests will be compared between active and sham rTMS groups in 12 weeks of follow up.
measure: fMRI
time frame: 5 weeks
description: The fMRI scan will be done at initial screen and at week 5 (after rTMS treatment) with resting-state fMRI and task activation fMRI with an IGT.
measure: Immunological markers
time frame: 12 weeks
description: Twenty milliliters of blood will be drawn from each participant. Plasma will be isolated from the whole blood after it has been centrifuged at 3000 g for 15 min at 4℃, and the will be immediately stored at -80℃. Cytokine and BDNF levels will be quantified using an antibody pair assay system (Flexia; BioSource Intl., Camarillo, CA). Sample processing and data analysis will be done according to the manufacturer's instructions.
The immunological parameters that we intend to analyze will include TNF-α, CRP, TGF-β1, IL-8, Il-10 and BDNF. The immunological markers will be measured from baseline to endpoint (week 12) in each patient group.
measure: Wechsler Memory Scale - third edition(WMS-III)
time frame: 12 weeks
description: WMS-III will be tested at initial screen and at the end of study (week 12) and compared between the active and sham rTMS groups.
measure: Wisconsin Card Sorting Test(WCST)
time frame: 12 weeks
description: WCST will be tested at initial screen and at the end of study (week 12) and compared between the active and sham rTMS groups.
measure: Continuous performance tests(CPT)
time frame: 12 weeks
description: CPT will be tested at initial screen and at the end of study (week 12) and compared between the active and sham rTMS groups.
measure: Side effect checklist
time frame: 12 weeks
description: To compare the side effect profiles using side effect checklist between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: Assessment of craving
time frame: 12 weeks
description: To compare the severity of craving between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: 17-item Hamilton Depression Rating Scale (HDRS)
time frame: 12 weeks
description: To compare the mood symptoms between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: World Health Organization's Quality of Life Assessment-Brief of Taiwan (WHOQOL-BREF TW)
time frame: 12 weeks
description: To compare the life quality (using WHOQOL-BREF TW) between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: Family APGAR index
time frame: 12 weeks
description: To compare the level of family support (using family APGAR index) between the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: The Opiate Treatment Index (OTI)
time frame: 12 weeks
description: To compare the OTI tween the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: Clinical Global Impressions (CGI)
time frame: 12 weeks
description: To compare the CGI tween the active and sham rTMS groups from baseline to endpoint (12 weeks).
measure: Barratt Impulsiveness Scale(BIS)
time frame: 12 weeks
description: To compare the BIS tween the active and sham rTMS groups from baseline to endpoint (12 weeks).
arm group label: Active rTMS treatment
arm group type: Experimental
description: The rTMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions.
arm group label: Sham rTMS treatment
arm group type: Sham Comparator
description: The rTMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min, with a figure-of-eight sham coil. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions.
intervention type: Device
intervention name: Active rTMS
description: The stimulator device was a Magstim super rapid magnetic stimulator (Magstim Company, Ltd., Wales, United Kingdom) with 4 booster modules equipped with a 70-mm air-cooled figure-eight-shaped coil. We performed rTMS on the left dorsolateral prefrontal cortex (DLPFC).The TMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
arm group label: Active rTMS treatment
intervention type: Device
intervention name: Sham rTMS
description: The stimulator device was a Magstim super rapid magnetic stimulator (Magstim Company, Ltd., Wales, United Kingdom) with 4 booster modules equipped with a 70-mm air-cooled figure-eight-shaped coil. We performed rTMS on the left dorsolateral prefrontal cortex (DLPFC).The TMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
arm group label: Sham rTMS treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tzu-Yun Wang
role: Principal Investigator
affiliation: National Cheng-Kung University Hospital
last name: Tzu-Yun Wang
phone: +886-6-2353535
phone ext: 5940
email: tzuyun0105@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Tzu-Yun Wang
investigator title: Doctor
mesh term: Opioid-Related Disorders
mesh term: Heroin Dependence