Brain Stimulation for Working Memory Deficits in Adolescents With ADHD

NCT ID: NCT03480737

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-03-30

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

Study Design

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

Study Groups

10 Hz rTMS

Group Type: EXPERIMENTAL

Magstim Super Rapid2 stimulator, 10 Hz condition

Intervention Type: DEVICE

10 Hz (2,000 pulses) at left DLPFC

Sham rTMS

Group Type: SHAM_COMPARATOR

Magstim Super Rapid2 stimulator, Sham condition

Intervention Type: DEVICE

sham

iTBS rTMS

Group Type: EXPERIMENTAL

Magstim Super Rapid2 stimulator, iTBS condition

Intervention Type: DEVICE

50 Hz, iTBS (600 pulses) at left DLPFC

Interventions

Magstim Super Rapid2 stimulator, 10 Hz condition

10 Hz (2,000 pulses) at left DLPFC

Intervention Type: DEVICE

Magstim Super Rapid2 stimulator, Sham condition

sham

Intervention Type: DEVICE

Magstim Super Rapid2 stimulator, iTBS condition

50 Hz, iTBS (600 pulses) at left DLPFC

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Ability to provide assent and have parent provide parental permission

2. English fluency

3. 13-17 years

4. List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean

5. Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean

6. IQ > 80

7. 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 or fillings)

7. Pacemaker

8. Implanted medication pump

9. Vagal nerve stimulator

10. Deep brain stimulator

11. TENS unit (unless removed completely for the study)

12. Ventriculo-peritoneal shunt

13. Signs of increased intracranial pressure

14. Intracranial lesion (including incidental finding on MRI)

15. History of head injury resulting in prolonged loss of consciousness

16. Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria met)

17. Chronic treatment with prescription medications that decrease cortical seizure threshold

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Rhode Island Foundation

OTHER

Sponsor Role: collaborator

Bradley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Kavanaugh, PsyD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

E. P. Bradley Hospital

East Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BradleyH

Identifier Type: -

Identifier Source: org_study_id