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

NCT04697316 — Not applicable, Completed, 63 participants, Hebrew University of Jerusalem

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Registry	NCT04697316
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	63 (Actual)
Sponsor	Hebrew University of Jerusalem (Other)
Conditions	Transcranial Direct Current Stimulation
Interventions	Transcranial Direct Current Stimulation, Sham (Device)
Dates	start 2021-08-01, primary completion 2022-11-22, completion 2023-06-01, first posted 2021-01-06, last updated 2024-03-07
Locations	1 site in Israel

-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.

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+Arms and interventions

Arm	Type	Interventions
ADHD tDCS	Experimental	Device: Transcranial Direct Current Stimulation
ADHD Sham	Sham comparator	Device: Sham
Healthy control tDCS	Experimental	Device: Transcranial Direct Current Stimulation
Healthy control Sham	Sham comparator	Device: Sham

Transcranial Direct Current Stimulation (Device): To stimulate the left DLPFC, the anode electrode will be placed over F3 and the cathode will be placed over F4. Each stimulation will be applied for 20 min at 2mA intensity.
Sham (Device): For the sham treatment, stimulation will be stopped after 30 seconds. Current will be renewed five times throughout the session for 2 seconds each time, to mimic the tDCS stimulation.

+Outcome measures

Primary outcomes

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
Navon task [through study completion, up to 1 hour after treatment]: change in accuracy, shorter RT's

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Hebrew University of Jerusalem	Jerusalem	Israel