Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
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|ClinicalTrials.gov Identifier: NCT04120129|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Facial Pain||Device: TMS Device: sham TMS coil||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||TMS, sham-TMS, and no treatment groups|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||TMS and sham TMS treatment group participants and researchers will be blinded to which treatment the participant receives|
|Official Title:||An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: TMS treatment
participants receive TMS treatment
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.
Other Name: TMS coil
Sham Comparator: sham TMS
participants receive control TMS treatment
Device: sham TMS coil
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.
No Intervention: non intervention
- Decreased Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) [ Time Frame: 7 months ]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.
- Length of decreased pain [ Time Frame: 7 months ]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
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): NCT04120129
|Contact: Mark Witcher, MD, PhDemail@example.com|
|Contact: Mallory Blackwood, MSfirstname.lastname@example.org|
|Principal Investigator:||Mark Witcher, MD, PhD||Surgeon|