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

Adult Attention Deficit Disorder Clinical Trial

— BMST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02206516
• Other study ID #: 0214-14
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 28, 2014
• Last updated: March 7, 2018
• Start date: July 2014
• Est. completion date: September 2018

Study information

• Verified date: March 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity

Intervention

Device:
• Transcranial Direct Current Stimulation

Locations

Country	Name	City	State
Israel	TASMC	Tel Aviv

Sponsors (4)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Brainsway, ElMindA Ltd, Ornim Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 weeks