rTMS for Emotional Difficulties in Verterans

Depression Clinical Trial

— rTMS  

Official title:

Developing a Novel rTMS Intervention for Transdiagnostic Psychosocial Rehabilitation: A Dose Finding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749967
• Other study ID #: D2886-P
• Secondary ID: RX002886
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: October 28, 2023

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 28, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• A negative urine pregnancy test, if female subject of childbearing potential.
• Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
• After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.

Exclusion Criteria:

• Clinically unstable medical disease:
• cardiovascular
• renal
• gastrointestinal
• pulmonary
• metabolic
• endocrine
• other
• CNS disease deemed progressive
• Moderate or severe traumatic brain injury (TBI) - (using VA/DoD Clinical Practice Guidelines)
• Pregnant females or those currently breast-feeding.
• Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia
• vascular
• Alzheimer's disease
• other types)
• Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted.
• See further explanation under protection from risk.
• Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial
• Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation.
• Currently taking medications that have short half-lives, lower the seizure threshold,

and do not have evidence of antidepressant efficacy. These include:

• high dose theophylline or stimulants such as methylphenidate
• patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
• An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant). History of seizures or a seizure disorder.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Health
• Psychosocial Impairment
• PTSD
• rTMS

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inventory of Psychosocial Functioning (IPF)	The IPF is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains of functioning. It was iteratively developed in 697 male and female Veteran stakeholders to identify relevant domains of functional impairment common in PTSD and related psychiatric dysfunction. Total score range=0-480. Increased scores pre- to 4 weeks post-treatment would indicate improved function.	4 weeks post-treatment
Primary	World Health Organization Quality of Life - Brief Form (WHOQOL-BF)	The WHOQOL-BREF is a 26-item self-assessment form. Questions are rated on a 5 point scale (from 1-5) Likert scale. Reflects four domains: physical, psychological, social and environment.	4 weeks post-treatment
Primary	Illness Intrusiveness Rating Scale (IIRS)	The IIRS is a self-report measure of the extent of psychosocial impairment secondary to illness. Total score range=13-91. Decreased scores pre- to 4 weeks post-treatment would indicate improved function.	4 weeks post-treatment
Secondary	Neurocognitive performance	Participants would complete a computerized battery, which includes well-validated computer-adaptations of neuropsychological tests. Tasks assess the following domains: information-processing speed, executive function, sustained attention/vigilance, verbal memory, working-memory capacity, inhibition/impulsivity, and sensorimotor function. Improved performance pre- to 4 weeks post-treatment would indicate improved function.	4 weeks post-treatment
Secondary	Inventory of Depression and Anxious Symptoms (IDAS-II)	Questions are rated on a scale from 1-5 and covers a wide array of psychological measures	4 weeks post-treatment
Secondary	Hamilton Scale for Depression (HAM-D)	Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe.	4 weeks post-treatment
Secondary	Mood and Anxiety Symptom Questionnaire (MASQ)	Questions designed to assess symptoms of general distress using a 5-point Likert scale ranging from 1"not at all" to 5 "extremely".	4 weeks post-treatment