A Trial of Two-Week Brain Stimulation for Teenagers With ADHD

NCT ID: NCT05102864

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2026-10-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active intermittent Theta Burst Stimulation

Participants will complete 10 daily sessions of active iTBS to the left dorsolateral prefrontal cortex

Group Type: ACTIVE_COMPARATOR

Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex

Intervention Type: DEVICE

iTBS will be administered to the left DLPFC for 10 consecutive days

Sham intermittent Theta Burst Stimulation

Participants will complete 10 daily sessions of sham iTBS to the left dorsolateral prefrontal cortex

Group Type: SHAM_COMPARATOR

Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex

Intervention Type: DEVICE

iTBS will be administered to the left DLPFC for 10 consecutive days

Interventions

Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex

iTBS will be administered to the left DLPFC for 10 consecutive days

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bradley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

E. P. Bradley Hospital

East Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BradleyH001

Identifier Type: -

Identifier Source: org_study_id