Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls

Not Applicable

Completed

• Conditions: Transcranial Direct Current Stimulation
• Interventions: Device: Transcranial Direct Current Stimulation; Device: Sham

• Registration Number: NCT04697316
• Lead Sponsor: Hebrew University of Jerusalem

Brief Summary

This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on cognitive functions which were found to be deficient amongst ADHD patients. The study will include 100 subjects, 50 of whom diagnosed with ADHD. Subjects will complete the ASRS questionnaire to measure ADHD symptoms severity. Next, subjects will complete a series of cognitive tasks, after which they will receive either tDCS treatment or a sham treatment. Finally, subjects will repeat the cognitive tasks. Later that day, a telephonic follow up will take place. ADHD symptoms will be assessed again the next day.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-08-01
• Primary Completion: 2022-11-22
• Study Completion: 2023-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Participation criteria for healthy participants

1. Right hand dominance.
2. No psychiatric nor neural diagnosis.
3. Participants must be able to comprehend the study's procedure and sign an informed consent.

Participation criteria for ADHD diagnosed participants

1. ADHD diagnosis (according to DSM V).

2. Right hand dominance.

3. Participants must be able to comprehend the study's procedure and sign an informed consent.

4. Participants who regularly use Methylphenidate will be required to avoid the medication for 24 hours prior to study and 12 hours post study.

Exclusion Criteria

• a. Other psychiatric diagnoses (additional to ADHD). b. Drug use (excluding Methylphenidate). c. Neurological disorders. d. Pacemaker, Insulin pump

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADHD tDCS	Transcranial Direct Current Stimulation	-
ADHD Sham	Sham	-
Healthy control Sham	Sham	-
Healthy control tDCS	Transcranial Direct Current Stimulation	-

Primary Outcome Measures

Name	Time	Method
Navon task	through study completion, up to 1 hour after treatment	change in accuracy, shorter RT's
N-back	through study completion	change in working memory: increase in hit rate
Stroop	through study completion, up to 1 hour after treatment	change in interference control: smaller interference effect
Stop-signal	through study completion, up to 1 hour after treatment	change in response inhibition: shorter SSRT
Time Reproduction task	through study completion, up to 1 hour after treatment	change in time perception: increased accuracy
Continuous Performance Task	through study completion, up to 1 hour after treatment	change in continuous concentration: increase in accuracy

Trial Locations

Locations (1)

Hebrew University of Jerusalem; 🇮🇱 Jerusalem, Israel