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

Phase 1

• Conditions: Adult Attention Deficit Disorder
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT02206516
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Primary Completion: 2017-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	Transcranial Direct Current Stimulation	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

TASMC; 🇮🇱 Tel Aviv, Israel