Trigeminal Nerve InjuriesNCT02633306
Transcranial Magnetic Stimulation for Facial Pain
A study testing transcranial magnetic stimulation in people with Trigeminal Nerve Injuries and Post-herpetic Neuralgia, run by University of Minnesota at 1 site in United States.
Trial summary
Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant suffering and disability. This study will explore the ability of fMRI to identify patients with complex oro-facial pain who respond to transcranial magnetic stimulation therapy. Specific Aims: 1. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Trigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 110
- Diagnosis of complex oro-facial pain made by the UMPhysicians Complex Facial Pain Clinic
- Alternative treatment of proven value not available as judged by the UMPhysicians Complex Facial Pain clinic
- One of the following types of facial pain as assessed by the Burchiel Patient Pain Rating Classification Questionnaire:
- trigeminal neuralgia Type 2 (TN2)
- trigeminal neuropathic pain (TNP)
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- trigeminal deafferentation pain (TDP)
- post herpetic neuralgia (PHN)
- atypical facial pain (AFP)
- nervus intermedius neuralgia (NIN)
- Willing and able to give informed consent
Who cannot join
- Subject diagnosed according to the MINI as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when Hamilton Depression Rating Scale -21≤26, or Beck Depression Inventory).
- Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.
- Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.
- Subject has a history of cranial surgery within 1 month of treatment.
- Subject has metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
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- Subject cannot pass the TMS Adult Safety Screen or the CMRR Safety Screen.
- Subject has severe and frequent headaches not part of their facial pain syndrome.
- Subject has a history of significant hearing loss.
- Subjects with a significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- MMSE ≤ 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Subject with a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
- Inadequate communication with the patient.
- Subject is under custodial care.
- Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- Subject with unstable physical disease such as unstable cardiac disease.
- Subject is currently on Benzodiazepine at a dose higher than 3 mg of Lorazepam or equivalent.
- Subject has had previous treatment with TMS.
- Women who are breast-feeding.
- Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation
Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant suffering and disability. This study will explore the ability of fMRI to identify patients with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.
Specific Aims:
- To establish baseline patterns of MRI in patients with chronic oro-facial pain without a definitive etiologic diagnosis.
- To estimate the rate of treatment success of transcranial stimulation of the primary motor cortex (M1) in these patients.
- To identify post-treatment MRI patterns that are associated with treatment success.
Read the detailed description
Methods: Patients diagnosed with complex oral or facial pain at the UMPhysicians Complex Facial Pain Clinic who meet inclusion and exclusion criteria will be offered participation in the study. They will undergo baseline evaluation for depression with the HAM-D and MADRAS scales and for quality of life with the WHOQOL-BREF scale. Pain will be assessed using a 10 point visual analogue scale. Resting and pcasl MRI will be done within 24 hours before the first treatment. Treatment will consist of five daily sessions of motor cortex stimulation contralateral to the pain. Visual analogue pain scores will be obtained just before each treatment. Rating scales, resting and pcasl MRI will be repeated within 24 hours and at 2 weeks after the last treatment. Analysis: FMRI activation patterns will be examined by the investigators and correlated with treatment outcomes with the goal of identifying fMRI characteristics that can select patients suitable for further study.
- Conditions
- Trigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain, Nervus Intermedius Neuralgia
- Being tested
- transcranial magnetic stimulation
- Keywords
- trigeminal region pain
- Medical subject headings
- Trigeminal Nerve Injuries, Neuralgia, Postherpetic, Facial Pain, Myoclonic Cerebellar Dyssynergia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | transcranial magnetic stimulation Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.
Measured: 7 days
Secondary outcomes (5)
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall
A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.
Measured: pre-treatment, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health
A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.
Measured: baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health
A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.
Measured: baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships
A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.
Measured: baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment
A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.
Measured: baseline, 3 and 7 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start1 Aug 2016
- Primary completion1 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trigeminal Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen J Haines, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633306
- Sponsor's protocol ID
- 1511M80284
- Status last verified
- Mar 2021
- First submitted
- 10 Dec 2015
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT02633306
- Acronym / sponsor ID
- 1511M80284
- Conditions
- Trigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain, Nervus Intermedius Neuralgia
- Keywords
- trigeminal region pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant suffering and disability. This study will explore the ability of fMRI to identify patients with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.
Specific Aims:
- To establish baseline patterns of MRI in patients with chronic oro-facial pain without a definitive etiologic diagnosis.
- To estimate the rate of treatment success of transcranial stimulation of the primary motor cortex (M1) in these patients.
- To identify post-treatment MRI patterns that are associated with treatment success.
Detailed description
Methods: Patients diagnosed with complex oral or facial pain at the UMPhysicians Complex Facial Pain Clinic who meet inclusion and exclusion criteria will be offered participation in the study. They will undergo baseline evaluation for depression with the HAM-D and MADRAS scales and for quality of life with the WHOQOL-BREF scale. Pain will be assessed using a 10 point visual analogue scale. Resting and pcasl MRI will be done within 24 hours before the first treatment. Treatment will consist of five daily sessions of motor cortex stimulation contralateral to the pain. Visual analogue pain scores will be obtained just before each treatment. Rating scales, resting and pcasl MRI will be repeated within 24 hours and at 2 weeks after the last treatment. Analysis: FMRI activation patterns will be examined by the investigators and correlated with treatment outcomes with the goal of identifying fMRI characteristics that can select patients suitable for further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: transcranial magnetic stimulationtranscranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 110
- Diagnosis of complex oro-facial pain made by the UMPhysicians Complex Facial Pain Clinic
- Alternative treatment of proven value not available as judged by the UMPhysicians Complex Facial Pain clinic
- One of the following types of facial pain as assessed by the Burchiel Patient Pain Rating Classification Questionnaire:
- Willing and able to give informed consent
Key exclusion criteria (29 listed)
- Subject diagnosed according to the MINI as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when Hamilton Depression Rating Scale -21≤26, or Beck Depression Inventory).
- Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.
- Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
- Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.
- Subject has a history of cranial surgery within 1 month of treatment.
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 |
|---|---|---|
| transcranial magnetic stimulationTreatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain. | Device | Transcranial Magnetic Stimulation |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 7 days
Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.
5 secondary outcomes
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall
Time frame: pre-treatment, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health
Time frame: baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health
Time frame: baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships
Time frame: baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment
Time frame: baseline, 3 and 7 days post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stephen J Haines, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Trigeminal Nerve Injuries and Post-herpetic Neuralgia, run by University of Minnesota 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 11 inclusion and 29 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: finished, as of the sponsor's last update on 8 Apr 2021. 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. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 7 days). 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 8 Apr 2021.