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NCT03480737 · ClinicalTrials.gov registry record · NA
Brain Stimulation for Working Memory Deficits in Adolescents With ADHD
A NA study, sponsored by Bradley Hospital.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT03480737 is a NA study that has completed, run by Bradley Hospital. The registered enrollment target is 14 participants.
The verdict
NCT03480737, a NA study, has completed, sponsored by Bradley Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study 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
- DEVICE Magstim Super Rapid2 stimulator, 10 Hz condition
- DEVICE Magstim Super Rapid2 stimulator, Sham condition
- DEVICE Magstim Super Rapid2 stimulator, iTBS condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2023-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03480737
The ClinicalTrials.gov registry entry for NCT03480737 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bradley Hospital, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Magstim Super Rapid2 stimulator, 10 Hz condition is the first listed.
NCT03480737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03480737 about?
NCT03480737 is a clinical study titled "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, ...
What is the current status of trial NCT03480737?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2019-11-01. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT03480737?
The interventions under investigation include: Magstim Super Rapid2 stimulator, 10 Hz condition (DEVICE), Magstim Super Rapid2 stimulator, Sham condition (DEVICE), Magstim Super Rapid2 stimulator, iTBS condition (DEVICE).
Who is sponsoring clinical trial NCT03480737?
This trial is sponsored by Bradley Hospital, which has 12 total clinical trials registered on ClinicalTrials.gov.
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