Recruiting

Observational Study

Sponsor:

Bradley Hospital

Code:

NCT05662280

Conditions

Working Memory

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Active Intermittent Theta Burst Stimulation

Sham Intermittent Theta Burst Stimulation

Study Details

Brief summary:

Working memory (WM) deficits are a transdiagnostic feature of adolescent psychopathology that substantially contribute to poor clinical and functional outcomes. This proposal will utilize a multimodal neuroscientific approach to investigate whether non-invasive brain stimulation can modulate the neural mechanisms underlying adolescent WM deficits. Directly in line with NIMH priorities, the researchers will identify the contributing roles of prefrontal and parietal regions in WM processes, as well as identify optimal targets and parameters for novel brain-based treatments in adolescent psychopathology. This study is funded by the NIMH-K23

Conditions

Working Memory

Study ID

NCT05662280

Start date

Dec 1, 2022

Status verified date

Aug, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Researchers will enroll a sample of adolescents (age 12-18 years) with working memory deficits and ADHD. Participation in this study will not require any adjustments to their clinical care. There are no costs to this study (participants compensated) and there are no expected long-term benefits to the participants. Participants will be compensated for each session. Participants can withdraw from the study at any time.

Inclusion Criteria

1. Ability to provide assent and have parent provide parental permission
2. English fluency of the participant and the legal guardian/parent
3. 12-18 years
4. Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean.
5. IQ > 80
6. 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: 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:

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, braces or fillings)
7. Non-removable makeup or piercings
8. Pacemaker
9. Implanted medication pump
10. Vagal nerve stimulator
11. Deep brain stimulator
12. TENS unit (unless removed completely for the study)
13. Ventriculo-peritoneal shunt
14. Signs of increased intracranial pressure
15. Intracranial lesion (including incidental finding on MRI)
16. History of head injury resulting in prolonged loss of consciousness
17. Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)
18. 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.
19. Active psychosis or mania
20. Current suicidal intent
21. Current pregnancy
22. Significant visual, hearing or speech impairment
23. Current wards of the state

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Active intermittent Theta Burst Stimulation

In a 2x2 factorial double-blind design, researchers will randomize a sample of adolescents with WM deficits to intermittent theta burst stimulation (iTBS) at the left dorsolateral prefrontal cortex (DLPFC) or inferior parietal lobule (IPL), based on each participant's structural brain MRI.

Participants in both arms will complete an active iTBS session and a sham iTBS session. The primary outcome will be theta-gamma coupling during WM demands, as measured via electroencephalography (EEG) during a Sternberg spatial WM task (SWMT) immediately before and after iTBS.

experimental: Sham intermittent Theta Burst Stimulation

In a 2x2 factorial double-blind design, researchers will randomize a sample of adolescents with WM deficits to intermittent theta burst stimulation (iTBS) at the left dorsolateral prefrontal cortex (DLPFC) or inferior parietal lobule (IPL), based on each participant's structural brain MRI.

Participants in both arms will complete an active iTBS session and a sham iTBS session. The primary outcome will be theta-gamma coupling during WM demands, as measured via electroencephalography (EEG) during a Sternberg spatial WM task (SWMT) immediately before and after iTBS.

Interventions

Active Intermittent Theta Burst Stimulation

Standard iTBS protocol with active coil

Sham Intermittent Theta Burst Stimulation

Standard iTBS protocol with active coil

Primary outcome measure

  • Change in Theta-Gamma Coupling After Sham iTBS [ Time Frame: Theta-gamma coupling will be obtained immediately before (i.e., pre-iTBS) and after iTBS (i.e., post-iTBS). There will be approximately 5 minutes between the pre and post EEG recordings. The change between pre-iTBS and post-iTBS is the outcome variable. ]
  • Change in Theta-Gamma Coupling after Active iTBS [ Time Frame: Theta-gamma coupling will be obtained immediately before (i.e., pre-iTBS) and after iTBS (i.e., post-iTBS). There will be approximately 5 minutes between the pre and post EEG recordings. The change between pre-iTBS and post-iTBS is the outcome variable. ]

Central Contacts and Locations

Central contacts

Brian Kavanaugh, PsyD ABPP

14014321359Brian_Kavanaugh@Brown.edu

Locations

E. P. Bradley Hospital

Recruiting

East Providence, Rhode Island, United States, 02915

Contacts

More Information

Sponsor

Bradley Hospital

Last update posted

May 1, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bradley Hospital on 2026-05-01.