Study Results
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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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-09-07
2023-12-29
Brief Summary
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Detailed Description
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The goal of this proposal is to evaluate preliminary participant response to a pilot, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a substance use disorder (SUD). An important focus of this application will be evaluating the acceptability, tolerability, and safety of sTMS in this population. To the investigators knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future treatment option for these prevalent disorders. However initial work in the acceptability, tolerability, and safety of this approach must be conducted first. This project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and improve quality of life for Veterans.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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active
active sTMS
sTMS
sTMS will be delivered following NeoSync guidelines using the device user
manual
sham
sham sTMS
sham sTMS
sham sTMS will be delivered following NeoSync guidelines using the device user manual
Interventions
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sTMS
sTMS will be delivered following NeoSync guidelines using the device user
manual
sham sTMS
sham sTMS will be delivered following NeoSync guidelines using the device user manual
Eligibility Criteria
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Inclusion Criteria
* between ages 18-70,
* Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
* ongoing medications and psychotherapy will be allowed to continue unchanged during the study
* for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population
Exclusion Criteria
* history of moderate or severe traumatic brain injury,
* current or prior neurologic disorder or lifetime history of
* seizure disorder
* CNS tumors
* stroke
* cerebral aneurysm,
* unstable medical condition,
* active suicidality as assessed with the Columbia-Suicide Severity Rating Scale
* primary psychotic disorder.
18 Years
70 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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John E McGeary, PhD
Role: PRINCIPAL_INVESTIGATOR
Providence VA Medical Center, Providence, RI
Locations
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Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States
Countries
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References
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Jampel J, Quinn MJ, Catalano JL, Benca-Bachman CB, Brick L, Philip NS, Swift RM, McGeary JE. Synchronised transcranial magnetic stimulation for substance use-disordered Veterans: protocol for the pilot sham-controlled acceptability trial. BMJ Open. 2023 Jan 30;13(1):e066175. doi: 10.1136/bmjopen-2022-066175.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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RX003338
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
D3338-P
Identifier Type: -
Identifier Source: org_study_id
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