Pain Clinical Trial
— TPDOfficial title:
Exploring the Feasibility and Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in a Healthy Population
NCT number | NCT04074811 |
Other study ID # | TPD-1 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 10, 2023 |
Est. completion date | April 10, 2023 |
Verified date | April 2023 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode of stimulation). Although it is only approved for two disorders, there has been substantial research into the potential of TMS to treat a wide range of neuropsychiatric disorders, including substance use disorders (SUDs). This project aims to develop an initial TMS protocol in a sample of healthy controls and to establish the feasibility and efficacy of using repetitive TMS (rTMS) to impact several carefully-selected cognitive, behavioral, and physiologic measures. This pilot project will enable the research team to gather baseline data using this new method and to plan longer-term programmatic studies focusing on populations with SUDs. The overarching aim of this project is to develop an rTMS protocol for use in the human laboratory setting with both healthy controls and individuals with SUDs. The investigators also hope to learn about the impact of high frequency rTMS over the DLPFC on multiple aspects of functioning including: cognitive control, impulsivity, thermal pain sensitivity, motivation, and mood.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 10, 2023 |
Est. primary completion date | April 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: - Healthy - Right handed - 21-60 years of age - IQ score greater than 80 - Eligible if using tobacco, alcohol, or marijuana fewer than 3 times per week; each "time" must be less than 3 cigarettes or drinks, or less than 1 marijuana "joint" Exclusion Criteria: - Under influence of any substances during any session - Use of illicit substances in the past 30 days - Pregnant - Medical conditions that prohibit the use of rTMS (e.g. history of seizures or medications that lower seizure threshold) - Current DSM-5 Axis I psychiatric disorders, or any history of substance use disorders. |
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stroop Task (cognitive control) | Examine the effect of rTMS stimulation on cognitive control as measured by the Stroop Color-Word task. | Change from pre- to 25-minutes post-rTMS stimulation in each session | |
Primary | Stop Signal Task (impulsivity) | Examine the effect of rTMS stimulation on impulsivity as measured by the Stop Signal Task. | Change from pre- to 15-minutes post-rTMS stimulation in each session | |
Primary | Pain Sensitivity | Examine the effect of rTMS stimulation on pain sensitivity as measured by thermal quantitative sensory threshold (QST) testing. | Change from pre- to 50-minutes post-rTMS stimulation in each session | |
Primary | Delay Discounting Task (cognitive control) | Examine the effect of rTMS stimulation on cognitive control as measured by the brief (2-min) monetary delay discounting task | Change from pre- to 10-minutes post-rTMS stimulation in each session | |
Secondary | Effort Choice Task (motivation) | Examine the effect of rTMS stimulation on behavioral responding as measured by the Effort Choice Task (number of responses on progressive ratio vs. fixed ratio schedules of reinforcement). | Change from pre- to 30-minutes post-rTMS stimulation in each session | |
Secondary | Mood | Examine the effect of rTMS stimulation on mood state as measured by the Positive and Negative Affect Schedule. | Change from pre- to 5-minutes post-rTMS stimulation in each session | |
Secondary | Peripheral Biomarkers | Examine the effect of rTMS stimulation on peripheral biomarkers as measured by the plasma concentrations (ng/ml) of brain derived neurotrophic factor (BDNF) and prolactin. | Change from pre- to 0-minutes post-rTMS stimulation in each session | |
Secondary | Monetary Incentive Delay Task (motivation) | Examine the effect of rTMS stimulation on behavioral responding as measured by the Monetary Incentive Delay Task | Change from pre- to 40-minutes post-rTMS stimulation in each session |
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