Transcranial Direct Current StimulationNCT04697316
Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls
A study testing Transcranial Direct Current Stimulation in people with Transcranial Direct Current Stimulation, run by Hebrew University of Jerusalem at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- a. Other psychiatric diagnoses (additional to ADHD). b. Drug use (excluding Methylphenidate). c. Neurological disorders. d. Pacemaker, Insulin pump
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Transcranial Direct Current Stimulation
- Being tested
- Transcranial Direct Current Stimulation, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD tDCS | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation |
| ADHD Sham | Sham comparator | Not described Receives: Device: Sham |
| Healthy control tDCS | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation |
| Healthy control Sham | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-back
change in working memory: increase in hit rate
Measured: through study completion
Stroop
change in interference control: smaller interference effect
Measured: through study completion, up to 1 hour after treatment
Stop-signal
change in response inhibition: shorter SSRT
Measured: through study completion, up to 1 hour after treatment
Time Reproduction task
change in time perception: increased accuracy
Measured: through study completion, up to 1 hour after treatment
Continuous Performance Task
change in continuous concentration: increase in accuracy
Measured: through study completion, up to 1 hour after treatment
Navon task
change in accuracy, shorter RT's
Measured: through study completion, up to 1 hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Aug 2021
- Primary completion22 Nov 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noa Beiman, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697316
- Sponsor's protocol ID
- tDCS-ADHD
- Status last verified
- Mar 2024
- First submitted
- 31 Dec 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT04697316
- Acronym / sponsor ID
- tDCS-ADHD
- Conditions
- Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- a. Other psychiatric diagnoses (additional to ADHD). b. Drug use (excluding Methylphenidate). c. Neurological disorders. d. Pacemaker, Insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationTo 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. | Device | ADHD tDCS, Healthy control tDCS |
| ShamFor 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. | Device | ADHD Sham, Healthy control Sham |
Primary outcome
N-back
Time frame: through study completion
change in working memory: increase in hit rate
Stroop
Time frame: through study completion, up to 1 hour after treatment
change in interference control: smaller interference effect
Stop-signal
Time frame: through study completion, up to 1 hour after treatment
change in response inhibition: shorter SSRT
Time Reproduction task
Time frame: through study completion, up to 1 hour after treatment
change in time perception: increased accuracy
Continuous Performance Task
Time frame: through study completion, up to 1 hour after treatment
change in continuous concentration: increase in accuracy
Navon task
Time frame: through study completion, up to 1 hour after treatment
change in accuracy, shorter RT's
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Transcranial Direct Current Stimulation, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-back (time frame: through study completion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.