rTMS for Emotional Difficulties in Verterans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-10-28

Brief Summary

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Mental illness rarely occurs as a single, easily categorized condition. Instead, multiple disorders often co-occur. This complicates the treatment plan for many Veterans, especially those suffering the most severe dysfunction. This also means that clinical research aimed at one specific disorder may not be optimized to treat the realworld presentation of neuropsychiatric illness. The investigators propose in this study to develop a novel, non-invasive brain stimulation treatment that would promote rehabilitation for Veterans suffering a wide range of emotional difficulties. More specifically, the investigators propose to up-regulate the brain circuitry that supports flexible problem solving and contending with daily demands. Rather than focusing on reducing the symptoms of a specific disorder to reduce the intrusion into daily life, the investigators propose to augment those brain circuits that promote adaptive cognition and thus quality of life.

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Detailed Description

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The investigators propose that because rTMS to dlPFC is targeting cognitive neurocircuitry integral to adaptive cognitive functioning, promoting neuroplasticity in this network with rTMS could be more precisely optimized to improve quality of life across psychosocial domains and across neuropsychiatric presentations. The investigators postulate that through up-regulating cognitive control circuitry with rTMS that an individual would have 1) enhanced capacity for successfully contending with the shifting contingencies of daily life and 2) improved ability to regulate intrusive affect and impulses. As a function of these processes an individual is expected to experience reduced psychosocial impairment. Thus, the investigators propose that rather than targeting specific symptom reductions in specific disorders, rTMS could be dosed for efficacy in enhancing psychosocial functioning. Such an approach has the potential to enhance rehabilitation for far more Veterans suffering a range of neuropsychiatric conditions.

Aim 1. Establish the dose-response curve for improved psychosocial functioning secondary to accelerated rTMS in a transdiagnostic anxious and depressed sample of Veterans.

Aim 2. Establish the safety, feasibility, and acceptability of an accelerated delivery schedule of therapeutic rTMS for improved psychosocial functioning in a transdiagnostic anxious and depressed sample of Veterans.

Exploratory Aim 3. Establish whether neurocognitive function demonstrates a dose-response function to accelerated rTMS similar to psychosocial functioning in a transdiagnostic anxious and depressed sample.

Note: COVID-19 pandemic put a pause on enrollment.

Conditions

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Mental Health Depression rTMS Anxiety PTSD Psychosocial Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Veterans will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of transdiagnostic psychosocial impairment. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

All participants will be randomized to 10 different active doses of accelerated, intermittent theta burst rTMS.

Study Groups

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Dose 1

All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.

Group Type EXPERIMENTAL