Using Combined Neuroimaging Techniques and Clinical Measures to Assess Feasibility of tDCS as an Intervention in Adult ADD.
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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).
Intervention: Transcranial Direct Current Stimulation (Device)
Outcomes
Primary Outcomes
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 Outcomes
- changes in functional activity after 4 weeks of tDCS treatment during response inhibition(6 weeks)