Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain. (NCT02321566) | Clinical Trial Compass
TerminatedPhase 1
Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
Stopped: Device manufacturer no longer supports implant covered under the IDE.
United States1 participantsStarted 2015-02
Plain-language 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 MCS. The study has as a single-arm design with the subject at baseline serving as a control for the response to MCS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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.