Trials / Completed
CompletedNCT03480737
Brain Stimulation for Working Memory Deficits in Adolescents With ADHD
Intermittent Theta Burst Stimulation for Working Memory Deficits in Adolescents With ADHD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Bradley Hospital · Academic / Other
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magstim Super Rapid2 stimulator, 10 Hz condition | 10 Hz (2,000 pulses) at left DLPFC |
| DEVICE | Magstim Super Rapid2 stimulator, Sham condition | sham |
| DEVICE | Magstim Super Rapid2 stimulator, iTBS condition | 50 Hz, iTBS (600 pulses) at left DLPFC |
Timeline
- Start date
- 2019-11-01
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
- First posted
- 2018-03-29
- Last updated
- 2025-09-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03480737. Inclusion in this directory is not an endorsement.