Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2006
Longer than P75 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2006
CompletedFirst Posted
Study publicly available on registry
July 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedApril 30, 2012
October 1, 2010
4.3 years
July 5, 2006
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
measured during the study period
Study Arms (2)
1
ACTIVE COMPARATORlaboratory pain assessment
2
ACTIVE COMPARATORtranscranial magnetic stimulation
Interventions
Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment. Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and "sham" TMS.
Eligibility Criteria
You may qualify if:
- For Healthy Adults:
- Between age of 21 and 60
- No prescription medications in previous 3 months
- No seizure history
- No depression
- Not suicidal
- No anxiety
- No hospitalizations or surgeries in previous 6 months
- No history of chronic pain conditions
- No implanted metal devices (e.g., pacemakers, metal plates, wires)
- Not pregnant
- No alcohol abuse/dependence history in previous 6 months
- No illicit drug use in previous 6 months
- Capable of reading, writing, giving consent, following instructions
- No history of brain surgery or history of loss of consciousness \>15 minutes
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey J. Borckardt, Ph.D.
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2006
First Posted
July 6, 2006
Study Start
July 1, 2006
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
April 30, 2012
Record last verified: 2010-10