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BMST: Feasibility of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention Deficit Disorder (ADD).

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02206516
Collaborator
ElMindA Ltd (Industry), Brainsway (Industry), Ornim Medical Ltd. (Industry)
20
Enrollment
1
Location
1
Arm
50
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation
 Phase 1

Detailed Description

This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients

Stimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG).

Device: Transcranial Direct Current Stimulation
Other Names:
  • neuroConn GmbH, Germany

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group. [6 weeks]

    Secondary Outcome Measures

    1. changes in functional activity after 4 weeks of tDCS treatment during response inhibition [6 weeks]

      ROI analysis of right Inferior frontal cortex will be measured during response inhibition in the Go/Nogo task at the end of the 4 weeks of treatment and will be compared to baseline measures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patients between the ages of 18-65(male and female)

    2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV

    3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.

    4. Gave informed consent for participation in the study

    5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study

    Exclusion Criteria:

    1. Suffering from other diagnosis on axis 1

    2. History of drug or alcohol abuse during the last year

    3. Inability to achieve satisfying level of communication with the subject

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TASMC Tel Aviv Israel

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center
    • ElMindA Ltd
    • Brainsway
    • Ornim Medical Ltd.

    Investigators

    • Principal Investigator: Talma Hendler, MD, PhD, TASMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tel-Aviv Sourasky Medical Center
    ClinicalTrials.gov Identifier:
    NCT02206516
    Other Study ID Numbers:
    • 0214-14
    First Posted:
    Aug 1, 2014
    Last Update Posted:
    Mar 8, 2018
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:
    Attention Deficit Disorder with Hyperactivity

    Study Results

    No Results Posted as of Mar 8, 2018