ClinicalTrials.gg
CompletedNCT03480737Updated Sep 15, 2025

Brain Stimulation for Working Memory Deficits in Adolescents With ADHD

An interventional study of Magstim Super Rapid2 stimulator, 10 Hz condition and Magstim Super Rapid2 stimulator, Sham condition in ADHD With Working Memory Deficits, sponsored by Bradley Hospital. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Bradley Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2023, 3 years 7 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States — 98 open to participants now, 116 under way, 5 of them phase 3. Attention Deficit Disorder with Hyperactivity · United States.

Enrollment
636th of 706
14 · median 70
Started
2019
with 31 others
No phase
283 of 807
50 open now
Registered
527th of 807
by date

Among the 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States, this one is the 636th largest by enrollment of the 706 interventional ones, is one of 32 that started in 2019, is one of 283 with no phase, and was the 527th registered.

By phase

807 studies; the count open now beside each. This study's row is marked.

No phasethis study283 · 50 open
Phase 4148 · 18 open
Phase 3121 · 4 open
Observational99 · 18 open
Phase 280 · 3 open
Phase 148 · 3 open
Phase 1/214 · 2 open
Phase 2/314 · 0 open

By the year they started

First in 1985; this study’s year is marked. 32 started in 2019.

Size and results

Median enrollment 70 across the 706 interventional studies, 115 across the 98 observational. Of the 644 that completed or were terminated, 302 (47%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 807 studies in Attention Deficit Disorder with Hyperactivity with a site in United States, or all of them as a file.
02

Study summary

Working memory (WM) is the foundational cognitive control process of holding information 'in mind' to execute goal-directed behaviors. WM deficits are an established component of ADHD. Despite being one of the strongest predictors of poor clinical and functional outcomes in pediatric mental health, there remains a dearth of available treatments for WM deficits.

Non-invasive brain stimulation hold tremendous promise in transforming psychiatry, as it takes a "brain-first" approach to treatment. The dorsolateral prefrontal cortex (DLPFC) is the known structural foundation of WM, and the interaction between slow and fast brain waves (i.e., "theta-gamma coupling [TGC]") is a neural, functional foundation of WM. Thus, the DLPFC and TGC are potential brain-based targets for the modulation of WM with brain stimulation. Intermittent theta burst stimulation (iTBS) is a novel paradigm that applies a three-minute dose of stimulation to the DLPFC at an intensity that directly mimics TGC dynamics.

The objective of this study is to test whether iTBS can enhance dysfunctional brain activity that causes working memory deficits. iTBS will be tested compared to standard or traditional transcranial magnetic stimulation (TMS), called 10 Hz TMS. It will also be compared to sham or fake TMS. Each participant receives a single session of each of these types of TMS. EEG will record neural activity during a working memory test immediately before and after each TMS session. If this study shows TMS can enhance dysfunctional brain activity, the next step will be to conduct a clinical trial to test if TMS can lead to a sustained, positive effect on working memory deficits.

03

Conditions studied

  • ADHD With Working Memory Deficits
04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to provide assent and have parent provide parental permission
  2. English fluency
  3. 13-17 years
  4. List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean
  5. Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean
  6. IQ > 80
  7. Clinical diagnosis of attention deficit hyperactivity disorder (ADHD): predominantly inattentive type, predominantly hyperactive/impulsive type, combined type, or unspecified type. Diagnostic criteria will be confirmed with NICHQ Vanderbilt Assessment Scales-Parent.

Exclusion criteria

Exclusion Criteria:

Participants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude participants in whom rTMS might result in increased risk of side effects or complications. Common TMS include metallic hardware in the body, cardiac pacemaker, patients with an implanted medication pumps or an intracardiac line, or prescription of medications known to lower seizure threshold. This accounts for the majority of the exclusion criteria listed:

  1. Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
  2. History of fainting spells of unknown or undetermined etiology that might constitute seizures
  3. History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
  4. Any progressive (e.g., neurodegenerative) neurological disorder
  5. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  6. Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
  7. Pacemaker
  8. Implanted medication pump
  9. Vagal nerve stimulator
  10. Deep brain stimulator
  11. TENS unit (unless removed completely for the study)
  12. Ventriculo-peritoneal shunt
  13. Signs of increased intracranial pressure
  14. Intracranial lesion (including incidental finding on MRI)
  15. History of head injury resulting in prolonged loss of consciousness
  16. Substance abuse or dependence within past six months (i.e., substance use disorder criteria met)
  17. Chronic treatment with prescription medications that decrease cortical seizure threshold
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    10 Hz rTMS

    Device: Magstim Super Rapid2 stimulator, 10 Hz condition

  • Sham comparator
    Sham rTMS

    Device: Magstim Super Rapid2 stimulator, Sham condition

  • Experimental
    iTBS rTMS

    Device: Magstim Super Rapid2 stimulator, iTBS condition

Interventions

  • DeviceMagstim Super Rapid2 stimulator, 10 Hz condition

    10 Hz (2,000 pulses) at left DLPFC

  • DeviceMagstim Super Rapid2 stimulator, Sham condition

    sham

  • DeviceMagstim Super Rapid2 stimulator, iTBS condition

    50 Hz, iTBS (600 pulses) at left DLPFC

06

What researchers measure

Primary outcomes

  1. Compared to sham and 10 Hz, iTBS will enhance theta-gamma coupling during working memory demands

    Time frame: Within 24 hours

Secondary outcomes

  1. Compared to sham and 10 Hz, iTBS will improve working memory test performance

    Time frame: Within 24 hours

07

Study locations

1 site
  • E. P. Bradley Hospital
    East Providence, Rhode Island 02915, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Mar 2023, 40 months.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 40 months is above that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 29, 2018
StartActual
Nov 1, 2019
Primary completionActual
Mar 30, 2023
CompletionActual
Mar 30, 2023
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03480737
Lead sponsor
Bradley Hospital
Collaborators
Thrasher Research Fund, Rhode Island Foundation
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Nov 1, 2019
Primary completion
Mar 30, 2023
Completion
Mar 30, 2023
Last update
Sep 15, 2025

Study contacts

Brian Kavanaugh, PsyD
principal investigator · E. P. Bradley Hospital/Alpert Medical School of Brown University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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