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OpenTrials
Completed

NCT Number: NCT03480737

Brain Stimulation for Working Memory Deficits in Adolescents With ADHD

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E. P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide assent and have parent provide parental permission
  • English fluency
  • 13-17 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.

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 rTMS might result in increased risk of side effects or complications. Common TMS 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. This accounts for the majority of the exclusion criteria listed:

  • 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
  • Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria met)
  • Chronic treatment with prescription medications that decrease cortical seizure threshold

Treatment and study plan

Magstim Super Rapid2 stimulator, 10 Hz condition

Device

10 Hz (2,000 pulses) at left DLPFC

Magstim Super Rapid2 stimulator, Sham condition

Device

sham

Magstim Super Rapid2 stimulator, iTBS condition

Device

50 Hz, iTBS (600 pulses) at left DLPFC

Primary outcomes

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

    Time frame: Within 24 hours

Secondary outcomes

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

    Time frame: Within 24 hours

Sponsors and collaborators

Lead sponsor

Bradley Hospital

Other

Collaborators

  • Rhode Island Foundation
  • Thrasher Research Fund

Registry information

Official study title

Intermittent Theta Burst Stimulation for Working Memory Deficits in Adolescents With ADHD

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2018
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.