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Completed

NCT Number: NCT04697316

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

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew University of Jerusalem

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participation criteria for healthy participants

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

Participation criteria for ADHD diagnosed participants

  • ADHD diagnosis (according to DSM V).
  • Right hand dominance.
  • Participants must be able to comprehend the study's procedure and sign an informed consent.
  • 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

Treatment and study plan

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.

Primary outcomes

  1. N-back

    Time frame: through study completion

    change in working memory: increase in hit rate

  2. Stroop

    Time frame: through study completion, up to 1 hour after treatment

    change in interference control: smaller interference effect

  3. Stop-signal

    Time frame: through study completion, up to 1 hour after treatment

    change in response inhibition: shorter SSRT

  4. Time Reproduction task

    Time frame: through study completion, up to 1 hour after treatment

    change in time perception: increased accuracy

  5. Continuous Performance Task

    Time frame: through study completion, up to 1 hour after treatment

    change in continuous concentration: increase in accuracy

  6. Navon task

    Time frame: through study completion, up to 1 hour after treatment

    change in accuracy, shorter RT's

Sponsors and collaborators

Lead sponsor

Hebrew University of Jerusalem

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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