Trials Sponsors Conditions Drugs Pricing

Conditions

Central Pain Syndromes Complex Regional Pain Syndrome (Types I and II, Involving the Upper Extremity)Glossopharyngeal Neuralgia Trigeminal Deafferentation Pain Trigeminal Neuralgia (Burchiel Type I)Trigeminal Neuralgia (Burchiel Type II)Trigeminal Neuropathic Pain Upper Extremity Pain Due to Deafferentation of the Cervical Spine

Outcome Measures

Primary Outcomes (1)

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
58 weeks after trial entry

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Device: Epidural Motor Cortex Stimulation

Interventions

Epidural Motor Cortex StimulationDevice

Treatment Arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:

Sponsors & Collaborators

Johns Hopkins University
Otherlead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

MeSH Terms

Conditions

Trigeminal NeuralgiaComplex Regional Pain SyndromesGlossopharyngeal Nerve Diseases

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesAutonomic Nervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

Frederick A Lenz, MD, PhD
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Enrollment

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

February 2015

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Treatment Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations