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Clinical Trials/NCT00349050
NCT00349050
Withdrawn
Phase 2

Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception

Medical University of South Carolina1 site in 1 countryJuly 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pain
Sponsor
Medical University of South Carolina
Locations
1
Primary Endpoint
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).
Status
Withdrawn
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.

Detailed Description

Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain. The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods. Participants with Neuropathic Pain: After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 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. The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC). Healthy Volunteers: In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
October 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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).

Time Frame: measured during the study period

Study Sites (1)

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