Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.

Johns Hopkins University1 site in 1 country1 target enrollmentFebruary 2015

ConditionsTrigeminal 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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Trigeminal Neuralgia (Burchiel Type I)
Sponsor: Johns Hopkins University
Enrollment: 1
Locations: 1
Primary Endpoint: Pain Assessments
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

November 21, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

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.
•Diagnosis of a somatoform pain disorder.

Outcomes

Primary Outcomes

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