<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/NCT03288363</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01527-44</org_study_id>
    <nct_id>NCT03288363</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation and Early Alzheimer's Disease (tDCS-AD)</brief_title>
  <acronym>tDCS-AD</acronym>
  <official_title>Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benjamin CALVET</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Esquirol</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with&#xD;
      many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which&#xD;
      remains of the field of research.&#xD;
&#xD;
      Its use remains very experimental, and concerns the exploration of cognitions, in healthy and&#xD;
      diseased subjects. There are not many studies on the elderly subject with Alzheimer's&#xD;
      disease, nor do they document the medium- and long-term effect (more than one month), nor the&#xD;
      effect on geriatric parameters such as Fragility indices and the risk of falls, especially at&#xD;
      home. These characteristics are decisive because they define the level of autonomy.&#xD;
&#xD;
      The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS&#xD;
      active) versus placebo (2-week tDCS group) for a three-month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alzheimer's disease and related syndromes have become a major public health priority issue in&#xD;
      France. Pharmacological treatments are ineffective and symptomatic, and only delay the&#xD;
      progression of the disease.&#xD;
&#xD;
      The management of Alzheimer's disease involves the development of multi-domain prevention&#xD;
      programs, including physical activity and neurostimulation by cognitive stimulation. They aim&#xD;
      to delay the appearance of fragility defined according to Fried by difficulties in walking,&#xD;
      weight loss, fatigue, lack of wrist strength and sedentary lifestyle.&#xD;
&#xD;
      Transcranial direct current stimulation (tDCS) is a stimulation technique using a low&#xD;
      intensity DC electric current that acts by modulating neuronal excitability at the cerebral&#xD;
      level.&#xD;
&#xD;
      According to recent data, by its action on the cerebral cortex, this simple and non-invasive&#xD;
      stimulation technique could prevent the effects of pathological aging, and reduce the&#xD;
      cognitive difficulties of the elderly concerning episodic memory, attention and executive&#xD;
      functions. These difficulties are also factors related to the risk of the elderly falling&#xD;
      (defined by the slowness of walking speed, reduced monopodal support time and the existence&#xD;
      of a falling antecedent).&#xD;
&#xD;
      TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with&#xD;
      many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which&#xD;
      remains of the field of research.&#xD;
&#xD;
      Its use remains very experimental, and concerns the exploration of cognitions, in healthy and&#xD;
      diseased subjects. There are not many studies on the elderly subject with Alzheimer's&#xD;
      disease, nor do they document the medium- and long-term effect (more than one month), nor the&#xD;
      effect on geriatric parameters such as Fragility indices and the risk of falls, especially at&#xD;
      home. These characteristics are decisive because they define the level of autonomy.&#xD;
&#xD;
      The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS&#xD;
      active) versus placebo (2-week tDCS group) on these criteria. This effect may stop or curb&#xD;
      cognitive decline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Anticipated">December 6, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 6, 2024</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>
    <intervention_model_description>sham versus stimulation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>the operator enters in the tDCS apparatus the code number of the kind of stimulation to deliver; This code number has been randomly assigned, and the correspondence list is not accessible by the different research professionals.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing between the active tDCS group with the placebo tDCS group, the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) score, 12 weeks after the start of the course, in subjects with early Alzheimer's disease</measure>
    <time_frame>3 months</time_frame>
    <description>difference of ADAS-Cog psychometric scale score between sham and stimulation groups</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 sessions tDCS (DC-Stimulator Plus -Neuroconn) during 2 Weeks on temporal cortex - each session : 30 minutes - 2 mA - 2 sessions per day - evaluation at 12 weeks post-treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>the same parameters of stimulation as with real current stimulation (time, parameters to be seen on the apparatus screen) 20 sessions during 2 Weeks on temporal cortex - each session : 30 minutes - 2 sessions per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)</description>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_label>tDCS</arm_group_label>
    <other_name>transcranial direct current stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A man or woman with probable Alzheimer's disease diagnosed according to the criteria&#xD;
             of the National Institute of Neurological and Communicative Disorders Association&#xD;
             (NINCDS-ADRDA)&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  Mini Mental State Examination ≥ 18&#xD;
&#xD;
          -  Clinical Demential Rating ≤ 1&#xD;
&#xD;
          -  Availability of a caregiver for assessments&#xD;
&#xD;
          -  Patient care in Day Hospital&#xD;
&#xD;
          -  Informed consent of the subject or his legal representative&#xD;
&#xD;
          -  General somatic state consistent with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presentation of contraindications to tDCS (presence of intracranial metal implants,&#xD;
             intracranial hypertension, comitial risk).&#xD;
&#xD;
          -  In case of anticholinesterase treatment: taken for at least 6 months and at a non&#xD;
             stable dose for 4 months.&#xD;
&#xD;
          -  Taking an antagonist treatment of NMDA receptors (anodic and cathodic) which cancels&#xD;
             post-stimulation effects (memantine).&#xD;
&#xD;
          -  Other types of dementia or neurological disorder according to Diagnostic and&#xD;
             Statistical Manual of Mental Disorders-5 (dementia with Lewy bodies, frontotemporal&#xD;
             dementia, Parkinson's disease, Huntington's disease, stroke, major head trauma,&#xD;
             cerebral neoplasia, systemic disease ...) , Which can lead to alterations in the&#xD;
             functioning of the central nervous system.&#xD;
&#xD;
          -  psychiatric disorder according to DSM-5, other than Alzheimer's disease including&#xD;
             amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar&#xD;
             disorder, major depressive episode in progress, psychosis, panic attacks, post&#xD;
             traumatic stress disorder And / or cognitive impairment not otherwise specified.&#xD;
&#xD;
          -  Any other disorder for which treatment is given priority over the treatment of&#xD;
             Alzheimer's disease or is likely to interfere with the study treatment or impairing&#xD;
             adherence.&#xD;
&#xD;
          -  Accommodation in an institution (EHPAD, EHPA) or request in progress.&#xD;
&#xD;
          -  Participation in other biomedical research during the study that may interfere with&#xD;
             the objectives of the study.&#xD;
&#xD;
          -  Person who had a recent change (&lt;1 month) of psychotropic treatment.&#xD;
&#xD;
          -  Person with a place of residence more than 80 km away.&#xD;
&#xD;
          -  Person without health insurance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Calvet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Esquirol</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Murielle Girard, PhD</last_name>
    <phone>0033555431028</phone>
    <email>murielle.girard@ch-esquirol-limoges.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Esquirol</name>
      <address>
        <city>Limoges</city>
        <zip>87025</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Murielle Girard</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Esquirol</investigator_affiliation>
    <investigator_full_name>Benjamin CALVET</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>tDCS</keyword>
  <keyword>cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03288363
org study id: 2016-A01527-44
nct id: NCT03288363
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with
      many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which
      remains of the field of research.

      Its use remains very experimental, and concerns the exploration of cognitions, in healthy and
      diseased subjects. There are not many studies on the elderly subject with Alzheimer's
      disease, nor do they document the medium- and long-term effect (more than one month), nor the
      effect on geriatric parameters such as Fragility indices and the risk of falls, especially at
      home. These characteristics are decisive because they define the level of autonomy.

      The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS
      active) versus placebo (2-week tDCS group) for a three-month period.
Alzheimer's disease and related syndromes have become a major public health priority issue in
      France. Pharmacological treatments are ineffective and symptomatic, and only delay the
      progression of the disease.

      The management of Alzheimer's disease involves the development of multi-domain prevention
      programs, including physical activity and neurostimulation by cognitive stimulation. They aim
      to delay the appearance of fragility defined according to Fried by difficulties in walking,
      weight loss, fatigue, lack of wrist strength and sedentary lifestyle.

      Transcranial direct current stimulation (tDCS) is a stimulation technique using a low
      intensity DC electric current that acts by modulating neuronal excitability at the cerebral
      level.

      According to recent data, by its action on the cerebral cortex, this simple and non-invasive
      stimulation technique could prevent the effects of pathological aging, and reduce the
      cognitive difficulties of the elderly concerning episodic memory, attention and executive
      functions. These difficulties are also factors related to the risk of the elderly falling
      (defined by the slowness of walking speed, reduced monopodal support time and the existence
      of a falling antecedent).

      TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with
      many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which
      remains of the field of research.

      Its use remains very experimental, and concerns the exploration of cognitions, in healthy and
      diseased subjects. There are not many studies on the elderly subject with Alzheimer's
      disease, nor do they document the medium- and long-term effect (more than one month), nor the
      effect on geriatric parameters such as Fragility indices and the risk of falls, especially at
      home. These characteristics are decisive because they define the level of autonomy.

      The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS
      active) versus placebo (2-week tDCS group) on these criteria. This effect may stop or curb
      cognitive decline.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: sham versus stimulation
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: the operator enters in the tDCS apparatus the code number of the kind of stimulation to deliver; This code number has been randomly assigned, and the correspondence list is not accessible by the different research professionals.
measure: Comparing between the active tDCS group with the placebo tDCS group, the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) score, 12 weeks after the start of the course, in subjects with early Alzheimer's disease
time frame: 3 months
description: difference of ADAS-Cog psychometric scale score between sham and stimulation groups
arm group label: tDCS
arm group type: Experimental
description: 20 sessions tDCS (DC-Stimulator Plus -Neuroconn) during 2 Weeks on temporal cortex - each session : 30 minutes - 2 mA - 2 sessions per day - evaluation at 12 weeks post-treatment
arm group label: sham stimulation
arm group type: Sham Comparator
description: the same parameters of stimulation as with real current stimulation (time, parameters to be seen on the apparatus screen) 20 sessions during 2 Weeks on temporal cortex - each session : 30 minutes - 2 sessions per day.
intervention type: Device
intervention name: tDCS
description: 20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)
arm group label: sham stimulation
arm group label: tDCS
other name: transcranial direct current stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Calvet, MD, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Esquirol
last name: Murielle Girard, PhD
phone: 0033555431028
email: murielle.girard@ch-esquirol-limoges.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Esquirol
investigator full name: Benjamin CALVET
investigator title: principal investigator
mesh term: Alzheimer Disease
sharing ipd: Undecided