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

NCT05102864 | Active Not Recruiting DMC FDA Device

• 1 other identifier: BradleyH001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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.

Study Arms (2)

Active intermittent Theta Burst Stimulation

ACTIVE COMPARATOR

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

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

Device: Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex

Interventions

Intermittent Theta Burst Stimulation to the Left Dorsolateral Prefrontal Cortex DEVICE

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

Active intermittent Theta Burst Stimulation; Sham intermittent Theta Burst Stimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ability to provide assent and have parent provide parental permission
• English fluency of the participant and the legal guardian/parent
• 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.

You may not qualify if:

• 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.)
• 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)

Sponsors & Collaborators

• Bradley Hospital: lead

Study Sites (1)

E. P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 2, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

US (1)