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

Transcranial Direct Current Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697316
• Other study ID #: tDCS-ADHD
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2024
• Source: Hebrew University of Jerusalem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 1, 2023
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

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Exclusion Criteria:

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

Related Conditions & MeSH terms

• Transcranial Direct Current Stimulation

Intervention

Device:
• Transcranial Direct Current Stimulation
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
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.

Locations

Country	Name	City	State
Israel	Hebrew University of Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

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