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The primary objective is to establish the feasibility of using TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who recieved TMS at several timepoints.
Participants will be randomized to either receive transcranial magnetic stimulation (TMS), Sham-TMS (a non-therapeutic TMS coil which sounds and feels similar to normal TMS), or standard treatment during the weeks of wait time before surgery for chronic orofacial pain (COFP). TMS is a noninvasive, painless magnetic device which, when applied to the head for a few minutes, has been shown to reduce pain in people with COFP. The sham TMS is a sub-therapeutic level of magnetcic stimulation which makes the same sound as normal TMS and causes a similar tingling of the skin.
Both those who receive this new pain intervention and those who do not will be asked to fill out a short online survey about their pain at several points during the study. The survey takes about 10 minutes to fill out and each of the 5 TMS sessions last 10 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS treatment | Experimental | participants receive TMS treatment |
|
| sham TMS | Sham Comparator | participants receive control TMS treatment |
|
| non intervention | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | Transcranial Magnetic Stimulation (TMS) is a noninvasive brain stimulation technique which produces short pulsatile magnetic fields (similar to that of an MRI) via two extracranial, figure 8-shaped electric coils which can induce a small, temporary, electric current in the brain currently approved and used for depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) | The primary objective is to establish the effectiveness of TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who received TMS at several timepoints. Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)will be used. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none & 10 worst possible) | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of altered pain | A secondary objective is to establish how long the effects of TMS last. This will be done by comparing self-reported pain scores prior to TMS, after TMS and at several timepoints thereafter in those who recieved the treatment. Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) will be used. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none & 10 worst possible) |
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Inclusion Criteria:
Exclusion Criteria:
Metallic implant in or near head Implanted stimulator on or near head recent suicidal ideation history of epilepsy, stroke, or unexplained seizure
- Need for urgent/emergent surgical decompression.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Witcher, MD, PhD | Contact | 540-224-5170 | mrwitcher@carilionclinic.org | |
| Mallory Blackwood, MS | Contact | 8047542825 | bmal@vt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Witcher, MD, PhD | Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Orthopedics and Neurosciences | Recruiting | Roanoke | Virginia | 24014 | United States |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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TMS, sham-TMS, and no treatment groups
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TMS and sham TMS treatment group participants and researchers will be blinded to which treatment the participant receives
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|
| sham TMS coil | Device | The sham TMS does cause some stimulation to the participant so that the participants get the sensation of treatment without any cortical excitation that TMS delivers. The sensation experienced is similar to the muscle twitching or finger tapping experienced by TMS participants. |
|
| 7 months |