Facial PainTGNNCT04120129
Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
A study testing TMS in people with Facial Pain, run by Carilion Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Facial Pain
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facial pain
- Considered an appropriate candidate for surgical or stereotactic intervention - microvascular decompression or stereotactic radiosurgery- ( includes factors such as overall health, chronic medication, comorbidities) and patient preference
- Between ages 18-100
- Able to participate in 5 consecutive TMS treatments
- Has at least 3 weeks between pre-op visit and scheduled date of surgery
- Able to provide consent and complete online questionnaires on their own
Who cannot join
- Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facial pain)
- contraindication to TMS, per device guidelines:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Institute for Orthopedics and Neurosciences
Roanoke, Virginia, 24014
Jordan Darden, PhD, 540-981-7942, jadarden@carilionclinic.org
About this study
Official title: An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
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.
Read the detailed description
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.
- Conditions
- Facial Pain
- Being tested
- TMS, sham TMS coil
- Keywords
- trigmenial neuralgia, Chronic orofacial pain
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called TMS coil
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.
sham TMS coilDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TMS treatment | Experimental | participants receive TMS treatment Receives: Device: TMS |
| sham TMS | Sham comparator | participants receive control TMS treatment Receives: Device: sham TMS coil |
| non intervention | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 months
Secondary outcomes (1)
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)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Aug 2020
- Primary completionFeb 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TMS, sham-TMS, and no treatment groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Witcher, Carilion Clinic
- Investigators
- Mark Witcher, MD, PhD, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120129
- Sponsor's protocol ID
- 19-371
- Acronym
- TGN
- Status last verified
- Nov 2020
- First submitted
- 23 Aug 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
- ClinicalTrials.gov ID
- NCT04120129
- Acronym / sponsor ID
- TGN / 19-371
- Conditions
- Facial Pain
- Keywords
- trigmenial neuralgia, Chronic orofacial pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- TMS, sham-TMS, and no treatment groups
| Arm | Type | Receives |
|---|---|---|
| TMS treatment | Experimental | Device: TMSparticipants receive TMS treatment |
| sham TMS | Sham comparator | Device: sham TMS coilparticipants receive control TMS treatment |
| non intervention | No intervention | –control group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facial pain
- Considered an appropriate candidate for surgical or stereotactic intervention - microvascular decompression or stereotactic radiosurgery- ( includes factors such as overall health, chronic medication, comorbidities) and patient preference
- Between ages 18-100
- Able to participate in 5 consecutive TMS treatments
- Has at least 3 weeks between pre-op visit and scheduled date of surgery
Key exclusion criteria (4 listed)
- Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facial pain)
- contraindication to TMS, per device guidelines:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSAlso: TMS coilTranscranial 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. | Device | TMS treatment |
| sham TMS coilThe 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. | Device | sham TMS |
Primary outcome
Changed 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. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none \& 10 worst possible)
1 secondary outcome
Length of altered pain
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Witcher, MD, PhD principal investigator
Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Facial Pain, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Witcher, MD, PhD (540-224-5170, mrwitcher@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.