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Brain Stimulation for Working Memory Deficits in Adolescents With ADHD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03480737
Enrollment
14
Registered
2018-03-29
Start date
2019-11-01
Completion date
2023-03-30
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD With Working Memory Deficits

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.

Interventions

DEVICEMagstim Super Rapid2 stimulator, 10 Hz condition

10 Hz (2,000 pulses) at left DLPFC

DEVICEMagstim Super Rapid2 stimulator, Sham condition

sham

DEVICEMagstim Super Rapid2 stimulator, iTBS condition

50 Hz, iTBS (600 pulses) at left DLPFC

Sponsors

Thrasher Research Fund
CollaboratorOTHER
Rhode Island Foundation
CollaboratorOTHER
Bradley Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frame
Compared to sham and 10 Hz, iTBS will enhance theta-gamma coupling during working memory demandsWithin 24 hours

Secondary

MeasureTime frame
Compared to sham and 10 Hz, iTBS will improve working memory test performanceWithin 24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026