Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
TerminatedPhase 1NCT02321566
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
- 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
- Upper Extremity Pain Due to Deafferentation of the Cervical Spine
- Central Pain Syndromes
- Interventions
- Device: Epidural Motor Cortex Stimulation
- Sponsor
- Johns Hopkins University
- Start date
- 2015-02
- Primary completion
- 2017-11-21
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Males and females who are greater than 18 years of age. 2. 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: 1. Facial pain, including trigeminal neuralgia Type 1, trigeminal neuralgia Type 2, trigeminal neuropathic pain, trigeminal deafferentation pain, symptomatic trigeminal neuralgia, and postherpetic neuralgia. 2. Complex Regional Pain Syndrome (Types I and II) involving the arm. 3. Both chronic and episodic forms of refractory Glossopharyngeal Neuralgia (GN). 4. Deafferentation of the cervical spine leading to pain of the upper extremity. 5. Central pain syndromes resulting from a prior cerebrovascular insult occurring at least 5 years prior to the study. 3. 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. 4. Subject has at least a score of 6 on the Visual Analog Scale of Pain at all three clinic visits prior to undergoing surgery. 5. Subject must be ambulatory. 6. 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. 7. 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. 8. Subject is able to read English, understand and cooperate with study pr…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02321566