Clinical Trials Directory

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

TypeNameDescription
DEVICEMagstim Super Rapid2 stimulator, 10 Hz condition10 Hz (2,000 pulses) at left DLPFC
DEVICEMagstim Super Rapid2 stimulator, Sham conditionsham
DEVICEMagstim Super Rapid2 stimulator, iTBS condition50 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

Source: ClinicalTrials.gov record NCT03480737. Inclusion in this directory is not an endorsement.