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

Primary Purpose

Trigeminal Neuralgia (Burchiel Type I), Trigeminal Neuralgia (Burchiel Type II), Trigeminal Neuropathic Pain

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Epidural Motor Cortex Stimulation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia (Burchiel Type I)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 procedures, and has signed a written informed consent form prior to any study procedures.

Exclusion Criteria:

  1. Subject had major surgery within three months prior to Baseline Visit 1 or has other surgery planned during the proposed study period.
  2. Subject is determined by medical consultant to have medical contraindications to undergoing surgery.
  3. Subject is pregnant or breast-feeding.
  4. Subject has a history of alcohol or drug abuse within the past 6 months and dependence within the past year.
  5. 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.
  6. Subject has a diagnosis of mental retardation.
  7. 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.
  8. Diagnosis of a somatoform pain disorder.

Sites / Locations

  • The Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2014
Last Updated
February 14, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02321566
Brief Title
Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
Official Title
Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Device manufacturer no longer supports implant covered under the IDE.
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Epidural Motor Cortex Stimulation
Primary Outcome Measure Information:
Title
Pain Assessments
Description
As measured by the VAS scale of Pain Intensity and Unpleasantness, the McGill Pain questionnaire, and the Leeds Assessment of Neuropathic Signs and Symptoms
Time Frame
58 weeks after trial entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick A Lenz, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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