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

Primary Purpose

Adult Attention Deficit Disorder

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation

About this trial

This is an interventional treatment trial for Adult Attention Deficit Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients between the ages of 18-65(male and female)
Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
Gave informed consent for participation in the study
If referred by the treating psychiatrist, he or she approves of the subjects participation in the study

Exclusion Criteria:

Suffering from other diagnosis on axis 1
History of drug or alcohol abuse during the last year
Inability to achieve satisfying level of communication with the subject

Sites / Locations

TASMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

changes in functional activity after 4 weeks of tDCS treatment during response inhibition

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.

Full Information

NCT ID

NCT02206516

First Posted

July 28, 2014

Last Updated

March 7, 2018

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

ElMindA Ltd, Brainsway, Ornim Medical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02206516

Brief Title

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

Acronym

BMST

Official Title

Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

ElMindA Ltd, Brainsway, Ornim Medical Ltd.

4. Oversight

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Attention Deficit Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation

Other Intervention Name(s)

neuroConn GmbH, Germany

Primary Outcome Measure Information:

Title

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.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

changes in functional activity after 4 weeks of tDCS treatment during response inhibition

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients between the ages of 18-65(male and female) Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments. Gave informed consent for participation in the study If referred by the treating psychiatrist, he or she approves of the subjects participation in the study Exclusion Criteria: Suffering from other diagnosis on axis 1 History of drug or alcohol abuse during the last year Inability to achieve satisfying level of communication with the subject

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Talma Hendler, MD, PhD

Organizational Affiliation

TASMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

TASMC

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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