ADHD With Working Memory DeficitsNCT03480737
Brain Stimulation for Working Memory Deficits in Adolescents With ADHD
A study testing Magstim Super Rapid2 stimulator, 10 Hz condition and Magstim Super Rapid2 stimulator, iTBS condition in people with ADHD With Working Memory Deficits, run by Bradley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD With Working Memory Deficits
- What is being tested?
- Magstim Super Rapid2 stimulator, 10 Hz condition and Magstim Super Rapid2 stimulator, iTBS condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Mar 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ability to provide assent and have parent provide parental permission
- English fluency
- 13-17 years
- List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean
- Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean
- IQ > 80
- 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.
Who cannot join
- 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 contraindications 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:
- 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
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
Show all 18Show fewer
- Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
- Pacemaker
- Implanted medication pump
- Vagal nerve stimulator
- Deep brain stimulator
- TENS unit (unless removed completely for the study)
- Ventriculo-peritoneal shunt
- Signs of increased intracranial pressure
- Intracranial lesion (including incidental finding on MRI)
- History of head injury resulting in prolonged loss of consciousness
- Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria met)
- Chronic treatment with prescription medications that decrease cortical seizure threshold
Trial locations and contacts
1 site in 1 country.
United States1 site
E. P. Bradley Hospital
East Providence, Rhode Island, 02915
About this study
Official title: Intermittent Theta Burst Stimulation for Working Memory Deficits in Adolescents With ADHD
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.
- Conditions
- ADHD With Working Memory Deficits
- Being tested
- Magstim Super Rapid2 stimulator, 10 Hz condition, Magstim Super Rapid2 stimulator, Sham condition, Magstim Super Rapid2 stimulator, iTBS condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Super Rapid2 stimulator, 10 Hz conditionDevice
10 Hz (2,000 pulses) at left DLPFC
Magstim Super Rapid2 stimulator, Sham conditionDevice
sham
Magstim Super Rapid2 stimulator, iTBS conditionDevice
50 Hz, iTBS (600 pulses) at left DLPFC
| Study group | Role | What they receive |
|---|---|---|
| 10 Hz rTMS | Experimental | Not described Receives: Device: Magstim Super Rapid2 stimulator, 10 Hz condition |
| Sham rTMS | Sham comparator | Not described Receives: Device: Magstim Super Rapid2 stimulator, Sham condition |
| iTBS rTMS | Experimental | Not described Receives: Device: Magstim Super Rapid2 stimulator, iTBS condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared to sham and 10 Hz, iTBS will enhance theta-gamma coupling during working memory demands
Measured: Within 24 hours
Secondary outcomes (1)
Compared to sham and 10 Hz, iTBS will improve working memory test performance
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Nov 2019
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD With Working Memory DeficitsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, Rhode Island Foundation
- Responsible party
- Sponsor
- Investigators
- Brian Kavanaugh, PsyD, Principal investigator, E. P. Bradley Hospital/Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480737
- Sponsor's protocol ID
- BradleyH
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2018
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst Stimulation for Working Memory Deficits in Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT03480737
- Acronym / sponsor ID
- BradleyH
- Conditions
- ADHD With Working Memory Deficits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, Rhode Island Foundation
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 29 Mar 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 Hz rTMS | Experimental | Device: Magstim Super Rapid2 stimulator, 10 Hz condition |
| Sham rTMS | Sham comparator | Device: Magstim Super Rapid2 stimulator, Sham condition |
| iTBS rTMS | Experimental | Device: Magstim Super Rapid2 stimulator, iTBS condition |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Ability to provide assent and have parent provide parental permission
- English fluency
- 13-17 years
- List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean
- Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean
Key exclusion criteria (18 listed)
- 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 contraindications 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:
- 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
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder
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 |
|---|---|---|
| Magstim Super Rapid2 stimulator, 10 Hz condition10 Hz (2,000 pulses) at left DLPFC | Device | 10 Hz rTMS |
| Magstim Super Rapid2 stimulator, Sham conditionsham | Device | Sham rTMS |
| Magstim Super Rapid2 stimulator, iTBS condition50 Hz, iTBS (600 pulses) at left DLPFC | Device | iTBS rTMS |
Primary outcome
Compared to sham and 10 Hz, iTBS will enhance theta-gamma coupling during working memory demands
Time frame: Within 24 hours
1 secondary outcome
Compared to sham and 10 Hz, iTBS will improve working memory test performance
Time frame: Within 24 hours
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Brian Kavanaugh, PsyD principal investigator
E. P. Bradley Hospital/Alpert Medical School of Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim Super Rapid2 stimulator, 10 Hz condition and Magstim Super Rapid2 stimulator, iTBS condition in people with ADHD With Working Memory Deficits, run by Bradley Hospital at 1 site in United States.
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 7 inclusion and 18 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 15 Sep 2025. 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 United States. 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?
Compared to sham and 10 Hz, iTBS will enhance theta-gamma coupling during working memory demands (time frame: Within 24 hours). 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 15 Sep 2025.