ADHDNCT05102864
A Trial of Two-Week Brain Stimulation for Teenagers With ADHD
A study testing Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex in people with ADHD, run by Bradley Hospital at 1 site in United States.
Trial summary
The objective of this clinical trial is to examine whether non-invasive brain stimulation can modulate dysfunctional brain dynamics underlying adolescent ADHD to subsequently improve clinical symptoms. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- ADHD
- What is being tested?
- Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to provide assent and have parent provide parental permission
- English fluency of the participant and the legal guardian/parent
- 12-18 years
- 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.
- Participants are allowed to continue clinical ADHD treatments. However, changes to ADHD treatments cannot be made during the entirety of study participation. Confirming a plan of treatment stability will occur as part of initial inclusion criteria. We will check on treatment stability at the start of each two-week phase with the participant and parent, and document accordingly. Changes to treatment will be reviewed by a physician and may result in study termination.
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 MRI or TMS might result in increased risk of side effects or complications. Common 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. These account for the majority of the exclusion criteria listed below:
- 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 24Show fewer
- Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants, braces or fillings)
- Non-removable makeup or piercings
- 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)
- Chronic treatment with prescription medications that decrease cortical seizure threshold, not including psychostimulant medication if deemed to be medically safe as part of the medical review process.
- Active psychosis or mania
- Current suicidal intent
- Current pregnancy
- Significant visual, hearing or speech impairment
- Current wards of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
E. P. Bradley Hospital
East Providence, Rhode Island, 02915
About this study
The objective of this clinical trial is to examine whether non-invasive brain stimulation can modulate dysfunctional brain dynamics underlying adolescent ADHD to subsequently improve clinical symptoms.
Read the detailed description
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 all primary childhood psychiatric disorders, most notably 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 holds 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 utilize the experimental therapeutics approach to investigate whether iTBS can lead to a lasting modulation of WM-related neural oscillations. In a crossover, double-blind design, a sample of adolescents (12-18 years old) with ADHD and WM deficits will complete a two-week course of active iTBS and a two-week course of sham iTBS to their left DLPFC. The central hypothesis is that iTBS at the left DLPFC will modulate TGC and subsequently improve attentional/WM abilities in adolescent WM deficits.
Aim 1 will examine the effect of iTBS on TGC and attention/WM (i.e., target engagement). Aim 2 will examine the relationship between change in TGC and attention/WM performance and symptoms (i.e., target validation). The exploratory aim will identify the neocortical circuitry underlying oscillatory modulation.
A secondary and clinical objective is to examine the safety/tolerability and preliminary efficacy of iTBS on ADHD-related symptoms.
Participants that complete the primary study procedures will be offered the opportunity to receive more iTBS sessions via participation in an optional open label arm. Participants will have the option of selecting an accelerated iTBS approach or the traditional, daily iTBS approach. Both approaches will administer 1800 pulses of iTBS to the left DLPFC per session. The accelerated protocol will administer iTBS twice per day for 10 days and the traditional protocol will administer iTBS once per day for 20 days.
- Conditions
- ADHD
- Being tested
- Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal CortexDevice
iTBS will be administered to the left DLPFC for 10 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Active intermittent Theta Burst Stimulation | Active comparator | Participants will complete 10 daily sessions of active iTBS to the left dorsolateral prefrontal cortex Receives: Device: Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex |
| Sham intermittent Theta Burst Stimulation | Sham comparator | Participants will complete 10 daily sessions of sham iTBS to the left dorsolateral prefrontal cortex Receives: Device: Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Theta-Gamma Coupling
EEG recording will be obtained while the participant completes the Sternberg Spatial Working Memory Test (SWMT). The coupling between theta phase and gamma amplitude will be extracted from the EEG during encoding and maintaining demands.
Measured: Theta-gamma coupling will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these four time points. This change is considered a single primary outcome variable.
Change in Parent-Reported ADHD, Working Memory, and Affective-Related Symptoms
Parents complete the BRIEF-2/Vanderbilt/PROMIS forms
Measured: ADHD/WM/affective symptoms will be obtained before the 1st session, and 24 hours after the 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these time points. This change is considered a single primary outcome variable.
Change in Working Memory Test Performance
Participants complete the Sternberg Spatial Working Memory Test
Measured: SSWMT performance will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these four time points. This change is considered a single primary outcome variable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102864
- Sponsor's protocol ID
- BradleyH001
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2021
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kavanaugh BC, Vigne MM, Legere C, Borden Z, Lynott E, Cheong D, Warren A, Acuff WL, Tirrell E, Festa EK, Jones SR, Jones RN, Spirito A, Carpenter LL. Intermittent theta burst stimulation modulates working memory-related theta-gamma coupling in adolescents with ADHD. medRxiv [Preprint]. 2026 Jul 15:2026.07.13.26357958. doi: 10.64898/2026.07.13.26357958.
PubMed 42528575
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Two-Week Brain Stimulation for Teenagers With ADHD
- ClinicalTrials.gov ID
- NCT05102864
- Acronym / sponsor ID
- BradleyH001
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Nov 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.
The objective of this clinical trial is to examine whether non-invasive brain stimulation can modulate dysfunctional brain dynamics underlying adolescent ADHD to subsequently improve clinical symptoms.
Detailed description
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 all primary childhood psychiatric disorders, most notably 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 holds 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 utilize the experimental therapeutics approach to investigate whether iTBS can lead to a lasting modulation of WM-related neural oscillations. In a crossover, double-blind design, a sample of adolescents (12-18 years old) with ADHD and WM deficits will complete a two-week course of active iTBS and a two-week course of sham iTBS to their left DLPFC. The central hypothesis is that iTBS at the left DLPFC will modulate TGC and subsequently improve attentional/WM abilities in adolescent WM deficits.
Aim 1 will examine the effect of iTBS on TGC and attention/WM (i.e., target engagement). Aim 2 will examine the relationship between change in TGC and attention/WM performance and symptoms (i.e., target validation). The exploratory aim will identify the neocortical circuitry underlying oscillatory modulation.
A secondary and clinical objective is to examine the safety/tolerability and preliminary efficacy of iTBS on ADHD-related symptoms.
Participants that complete the primary study procedures will be offered the opportunity to receive more iTBS sessions via participation in an optional open label arm. Participants will have the option of selecting an accelerated iTBS approach or the traditional, daily iTBS approach. Both approaches will administer 1800 pulses of iTBS to the left DLPFC per session. The accelerated protocol will administer iTBS twice per day for 10 days and the traditional protocol will administer iTBS once per day for 20 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active intermittent Theta Burst Stimulation | Active comparator | Device: Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal CortexParticipants will complete 10 daily sessions of active iTBS to the left dorsolateral prefrontal cortex |
| Sham intermittent Theta Burst Stimulation | Sham comparator | Device: Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal CortexParticipants will complete 10 daily sessions of sham iTBS to the left dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ability to provide assent and have parent provide parental permission
- English fluency of the participant and the legal guardian/parent
- 12-18 years
- Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean.
- IQ > 80
Key exclusion criteria (24 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 MRI or TMS might result in increased risk of side effects or complications. Common 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. These account for the majority of the exclusion criteria listed below:
- 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 |
|---|---|---|
| Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal CortexiTBS will be administered to the left DLPFC for 10 consecutive days | Device | Active intermittent Theta Burst Stimulation, Sham intermittent Theta Burst Stimulation |
Primary outcome
Change in Theta-Gamma Coupling
Time frame: Theta-gamma coupling will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these four time points. This change is considered a single primary outcome variable.
EEG recording will be obtained while the participant completes the Sternberg Spatial Working Memory Test (SWMT). The coupling between theta phase and gamma amplitude will be extracted from the EEG during encoding and maintaining demands.
Change in Parent-Reported ADHD, Working Memory, and Affective-Related Symptoms
Time frame: ADHD/WM/affective symptoms will be obtained before the 1st session, and 24 hours after the 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these time points. This change is considered a single primary outcome variable.
Parents complete the BRIEF-2/Vanderbilt/PROMIS forms
Change in Working Memory Test Performance
Time frame: SSWMT performance will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these four time points. This change is considered a single primary outcome variable.
Participants complete the Sternberg Spatial Working Memory Test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 42528575Kavanaugh BC, Vigne MM, Legere C, Borden Z, Lynott E, Cheong D, Warren A, Acuff WL, Tirrell E, Festa EK, Jones SR, Jones RN, Spirito A, Carpenter LL. Intermittent theta burst stimulation modulates working memory-related theta-gamma coupling in adolescents with ADHD. medRxiv [Preprint]. 2026 Jul 15:2026.07.13.26357958. doi: 10.64898/2026.07.13.26357958.
- 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.
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 Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex in people with ADHD, 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 24 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: under way, not looking for participants, as of the sponsor's last update on 9 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Theta-Gamma Coupling (time frame: Theta-gamma coupling will be obtained before the 1st session, and 24 hours after the 1st, 5th, and 10th sessions. Statistical modeling will examine the CHANGE across these four time points. This change is considered a single primary outcome variable.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05102864, which also lists 1 linked publication.
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 9 Sep 2025.