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

NCT02321566 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-02-18

No results posted yet for this study

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.

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

Sponsors & Collaborators

Principal Investigators

  • Frederick A Lenz, MD, PhD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-11-21
Completion
2017-11-21

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02321566 on ClinicalTrials.gov