Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00349050 |
|
Recruitment Status :
Withdrawn
First Posted : July 6, 2006
Last Update Posted : April 30, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain Trigeminal Neuralgia Neuropathic Pain | Device: laboratory pain assessment Procedure: transcranial magnetic stimulation | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
| Arm | Intervention/treatment |
|---|---|
|
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. |
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349050
| 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 | |
| Principal Investigator: | Jeffrey J. Borckardt, Ph.D. | Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina |
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00349050 History of Changes |
| Other Study ID Numbers: |
K23NS050485-01A2 ( U.S. NIH Grant/Contract ) K23NS050485-01A2 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 6, 2006 Key Record Dates |
| Last Update Posted: | April 30, 2012 |
| Last Verified: | October 2010 |
|
trigeminal neuralgia neuropathic pain complex regional pain syndrome reflex sympathetic dystrophy pain |
chronic pain transcranial magnetic stimulation TMS laboratory pain assessment |
|
Trigeminal Neuralgia Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations |
Signs and Symptoms Trigeminal Nerve Diseases Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases |