Brain Stimulation for Working Memory Deficits in Adolescents With ADHD

NCT03480737 | Completed DMC FDA Device

• 1 other identifier: BradleyH
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Compared to sham and 10 Hz, iTBS will enhance theta-gamma coupling during working memory demands

  Within 24 hours

Secondary Outcomes (1)

• Compared to sham and 10 Hz, iTBS will improve working memory test performance

  Within 24 hours

Study Arms (3)

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

Interventions

Magstim Super Rapid2 stimulator, 10 Hz condition DEVICE

10 Hz (2,000 pulses) at left DLPFC

10 Hz rTMS

Magstim Super Rapid2 stimulator, Sham condition DEVICE

sham

Sham rTMS

Magstim Super Rapid2 stimulator, iTBS condition DEVICE

50 Hz, iTBS (600 pulses) at left DLPFC

iTBS rTMS

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ability to provide assent and have parent provide parental permission
• English fluency
• 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.

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 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

Sponsors & Collaborators

• Bradley Hospital: lead
• Thrasher Research Fund: collaborator
• Rhode Island Foundation: collaborator

Study Sites (1)

E. P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

Location

Study Officials

• Brian Kavanaugh, PsyD

  E. P. Bradley Hospital/Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 29, 2018
• Study Start: November 1, 2019
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)