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

Sponsor
Hebrew University of Jerusalem (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04697316
Collaborator
(none)
100
4
5

Study Details

Study Description

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 CAARS 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation
  • Device: Sham
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ADHD tDCS

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 Comparator: ADHD Sham

Device: 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.

Experimental: Healthy control tDCS

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 Comparator: Healthy control Sham

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. N-back [through study completion, about six months]

    improved working memory: increase in Hit rate

  2. Stroop [through study completion, about six months]

    improved interference control: shorter RTs, increase in correct responses

  3. Stop-signal [through study completion, about six months]

    improved response inhibition: shorter RTs

  4. Time Reproduction task [through study completion, about six months]

    improved time perception: increased accuracy

  5. Continuous Performance Task [through study completion, about six months]

    improved continuous concentration: shorter RT's, decrease in errors

  6. Navon task [through study completion, about six months]

    improved accuracy, shorter RT's

Secondary Outcome Measures

  1. ADHD symptoms - CAARS questionnaire [through study completion, about six months]

    decrease in symptoms severity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hebrew University of Jerusalem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noa Beiman, Principal Investigator, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier:
NCT04697316
Other Study ID Numbers:
  • tDCS-ADHD
First Posted:
Jan 6, 2021
Last Update Posted:
Jan 6, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 6, 2021