Novel rTMS Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety, Depression, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/9/2019 |
| Start Date: | February 1, 2019 |
| End Date: | January 1, 2020 |
| Contact: | Lisa M McTeague, PhD |
| Email: | mcteague@musc.edu |
| Phone: | (843) 577-5011 |
Developing a Novel rTMS Intervention for Transdiagnostic Psychosocial Rehabilitation: A Dose Finding Study
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.
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.
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.
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.
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)
- 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.
We found this trial at
1
site
Charleston, South Carolina 29401
Principal Investigator: Lisa M. McTeague, PhD
Phone: 843-789-6707
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