Trigeminal Neuralgia (Burchiel Type I)Phase 1NCT02321566
Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
A Phase 1 study testing Epidural Motor Cortex Stimulation in people with Trigeminal Neuralgia (Burchiel Type I) and Trigeminal Neuralgia (Burchiel Type II), run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is an open-label study to determine the feasibility of Motor Cortex Stimulation (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will be delivered by use of an electrode and pulse generator, which are FDA approved for spinal cord stimulation but are not approved for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia (Burchiel Type I), Trigeminal Neuralgia (Burchiel Type II), Trigeminal Neuropathic Pain
- What is being tested?
- Epidural Motor Cortex Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 21 Nov 2017
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who are greater than 18 years of age.
- Subject has a diagnosis of chronic pain involving the face, upper extremity, or throat, as determined by a review of medical records, history and physical examination. The types of chronic pain eligible for the study are:
- Facial pain, including trigeminal neuralgia Type 1, trigeminal neuralgia Type 2, trigeminal neuropathic pain, trigeminal deafferentation pain, symptomatic trigeminal neuralgia, and postherpetic neuralgia.
- Complex Regional Pain Syndrome (Types I and II) involving the arm.
- Both chronic and episodic forms of refractory Glossopharyngeal Neuralgia (GN).
- Deafferentation of the cervical spine leading to pain of the upper extremity.
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- Central pain syndromes resulting from a prior cerebrovascular insult occurring at least 5 years prior to the study.
- Subject determined to be treatment-resistant for at least one year prior to the Screening Visit as demonstrated by clinical evidence (determined by review of medical records and discussion with referring pain specialist, anesthesiologist, or neurologist treating chronic pain). The patient must not have responded to treatment with three adequate regimens of medication including one in each of the following categories: antiepileptic drugs, opioids, and antidepressant medications. The trial period for each medication should be at least four weeks, and the two trials must be within the previous 5 years.
- Subject has at least a score of 6 on the Visual Analog Scale of Pain at all three clinic visits prior to undergoing surgery.
- Subject must be ambulatory.
- Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or intrauterine device [IUD]). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at baseline Visits 1 and 2.
- Subject is assessed by psychologist with respect to i) the role of psychological factors, including psychological comorbidities, in their chronic pain, ii) their ability to rate pain and make decisions during the extraoperative stimulation trial, and iii) to participate in decision-making capacity to provide informed consent.
- Subject is able to read English, understand and cooperate with study procedures, and has signed a written informed consent form prior to any study procedures.
Who cannot join
- Subject had major surgery within three months prior to Baseline Visit 1 or has other surgery planned during the proposed study period.
- Subject is determined by medical consultant to have medical contraindications to undergoing surgery.
- Subject is pregnant or breast-feeding.
- Subject has a history of alcohol or drug abuse within the past 6 months and dependence within the past year.
- Subject has a medical illness/condition, co-morbid psychiatric illness, and/or abnormal diagnostic finding that would interfere with the completion of the study, confound the results of the study, or pose risk to the patient.
- Subject has a diagnosis of mental retardation.
- Subject has a distinct neurological condition not included in the list of chronic pain syndromes studied in this protocol, or a history of traumatic brain injury associated with loss of consciousness of > 1 hour and/or intracranial/epidural/subdural bleeding.
- Diagnosis of a somatoform pain disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
This study is an open-label study to determine the feasibility of Motor Cortex Stimulation (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will be delivered by use of an electrode and pulse generator, which are FDA approved for spinal cord stimulation but are not approved for MCS. The study has as a single-arm design with the subject at baseline serving as a control for the response to MCS.
- Conditions
- Trigeminal Neuralgia (Burchiel Type I), Trigeminal Neuralgia (Burchiel Type II), Trigeminal Neuropathic Pain, Trigeminal Deafferentation Pain, Complex Regional Pain Syndrome (Types I and II, Involving the Upper Extremity), Glossopharyngeal Neuralgia
- Being tested
- Epidural Motor Cortex Stimulation
- Medical subject headings
- Trigeminal Neuralgia, Complex Regional Pain Syndromes, Glossopharyngeal Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Motor Cortex StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | A craniotomy will be performed for the placement of an epidural motor cortex stimulation lead in the context of subjects with chronic facial, upper extremity, and throat pain. If the stimulation is successful during a trial period with externalized lead cabling, the system cabling will be internalized and connected to an internal implantable pulse generator to power and control the system for the duration of the trial. Receives: Device: Epidural Motor Cortex Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessments
As measured by the VAS scale of Pain Intensity and Unpleasantness, the McGill Pain questionnaire, and the Leeds Assessment of Neuropathic Signs and Symptoms
Measured: 58 weeks after trial entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Why it stopped: Device manufacturer no longer supports implant covered under the IDE.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Neuralgia (Burchiel Type I)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick A Lenz, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321566
- Sponsor's protocol ID
- NA_00093333
- Status last verified
- Feb 2019
- First submitted
- 17 Dec 2014
- Last updated
- 18 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
- ClinicalTrials.gov ID
- NCT02321566
- Acronym / sponsor ID
- NA_00093333
- Conditions
- Trigeminal Neuralgia (Burchiel Type I), Trigeminal Neuralgia (Burchiel Type II), Trigeminal Neuropathic Pain, Trigeminal Deafferentation Pain, Complex Regional Pain Syndrome (Types I and II, Involving the Upper Extremity), Glossopharyngeal Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device manufacturer no longer supports implant covered under the IDE.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 22 Dec 2014 (estimated)
- 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.
This study is an open-label study to determine the feasibility of Motor Cortex Stimulation (MCS) in the treatment of patients with chronic pain of the face or upper extremity. MCS will be delivered by use of an electrode and pulse generator, which are FDA approved for spinal cord stimulation but are not approved for MCS. The study has as a single-arm design with the subject at baseline serving as a control for the response to MCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Epidural Motor Cortex StimulationA craniotomy will be performed for the placement of an epidural motor cortex stimulation lead in the context of subjects with chronic facial, upper extremity, and throat pain. If the stimulation is successful during a trial period with externalized lead cabling, the system cabling will be internalized and connected to an internal implantable pulse generator to power and control the system for the duration of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males and females who are greater than 18 years of age.
- Subject has a diagnosis of chronic pain involving the face, upper extremity, or throat, as determined by a review of medical records, history and physical examination. The types of chronic pain eligible for the study are:
- Subject determined to be treatment-resistant for at least one year prior to the Screening Visit as demonstrated by clinical evidence (determined by review of medical records and discussion with referring pain specialist, anesthesiologist, or neurologist treating chronic pain). The patient must not have responded to treatment with three adequate regimens of medication including one in each of the following categories: antiepileptic drugs, opioids, and antidepressant medications. The trial period for each medication should be at least four weeks, and the two trials must be within the previous 5 years.
- Subject has at least a score of 6 on the Visual Analog Scale of Pain at all three clinic visits prior to undergoing surgery.
- Subject must be ambulatory.
Key exclusion criteria (8 listed)
- Subject had major surgery within three months prior to Baseline Visit 1 or has other surgery planned during the proposed study period.
- Subject is determined by medical consultant to have medical contraindications to undergoing surgery.
- Subject is pregnant or breast-feeding.
- Subject has a history of alcohol or drug abuse within the past 6 months and dependence within the past year.
- Subject has a medical illness/condition, co-morbid psychiatric illness, and/or abnormal diagnostic finding that would interfere with the completion of the study, confound the results of the study, or pose risk to the patient.
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 |
|---|---|---|
| Epidural Motor Cortex Stimulation | Device | Treatment Arm |
Primary outcome
Pain Assessments
Time frame: 58 weeks after trial entry
As measured by the VAS scale of Pain Intensity and Unpleasantness, the McGill Pain questionnaire, and the Leeds Assessment of Neuropathic Signs and Symptoms
Results and safety
The study was stopped early (reason given: Device manufacturer no longer supports implant covered under the IDE.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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.
Frederick A Lenz, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epidural Motor Cortex Stimulation in people with Trigeminal Neuralgia (Burchiel Type I) and Trigeminal Neuralgia (Burchiel Type II), run by Johns Hopkins University 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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Feb 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Device manufacturer no longer supports implant covered under the IDE.). Results are not available in the source record.
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?
Pain Assessments (time frame: 58 weeks after trial entry). 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 18 Feb 2019.