Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00349050
First received: July 5, 2006
Last updated: April 26, 2012
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Pain
Trigeminal Neuralgia
Neuropathic Pain
Device: laboratory pain assessment
Procedure: transcranial magnetic stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
laboratory pain assessment
Device: laboratory pain assessment
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.
Active Comparator: 2
transcranial magnetic stimulation
Procedure: transcranial magnetic stimulation
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  • 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
  • No history of autoimmune or endocrine disorder
  • No significant anxiety about entering MRI scanner

For Patients with neuropathic pain:

  • Between age of 21 and 75
  • No seizure history
  • Not taking medications shown to increase seizure risk (6 months)
  • Not suicidal
  • No hospitalizations or surgeries in previous 3 months
  • 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
  • Chronic pain (>6 months), not significantly relieved by pharmacological treatment
  • No significant anxiety about entering MRI scanner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349050

Locations
United States, South Carolina
Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Jeffrey J. Borckardt, Ph.D. Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00349050     History of Changes
Other Study ID Numbers: K23NS050485-01A2, K23NS050485-01A2
Study First Received: July 5, 2006
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
trigeminal neuralgia
neuropathic pain
complex regional pain syndrome
reflex sympathetic dystrophy
pain
chronic pain
transcranial magnetic stimulation
TMS
laboratory pain assessment

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on April 15, 2014