NCT04697316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

December 31, 2020

Last Update Submit

March 4, 2024

Conditions

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (6)

  • N-back

    change in working memory: increase in hit rate

    through study completion

  • Stroop

    change in interference control: smaller interference effect

    through study completion, up to 1 hour after treatment

  • Stop-signal

    change in response inhibition: shorter SSRT

    through study completion, up to 1 hour after treatment

  • Time Reproduction task

    change in time perception: increased accuracy

    through study completion, up to 1 hour after treatment

  • Continuous Performance Task

    change in continuous concentration: increase in accuracy

    through study completion, up to 1 hour after treatment

  • Navon task

    change in accuracy, shorter RT's

    through study completion, up to 1 hour after treatment

Study Arms (4)

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

Interventions

Transcranial Direct Current StimulationDEVICE

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.

ADHD tDCSHealthy control tDCS
ShamDEVICE

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.

ADHD ShamHealthy control Sham

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew University of Jerusalem

Jerusalem, Israel

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 6, 2021

Study Start

August 1, 2021

Primary Completion

November 22, 2022

Study Completion

June 1, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)