Trials Sponsors Conditions Drugs Pricing

Conditions

Brachial Plexus Avulsion Facial Pain Neuropathic Pain Phantom Limb Pain of the Upper Extremities Post-stroke Pain

Keywords

Motor Cortex StimulationNeuropathic pain

Outcome Measures

Primary Outcomes (1)

Visual Analog Scale (VAS)
The primary analysis of effectiveness is based on the mean differences in changes from the period-specific baseline in VAS scores when patients are receiving 3 month of active vs. 3 months of sham stimulation on a double-blinded fashion.
Approximately 7 months

Secondary Outcomes (10)

Visual Analog Scale, responder
Participants will be followed for approximatley 18 months
Neuropathic Pain Symptom Inventory (NPSI)
Participants will be followed for approximatley 18 months

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Device: Motor Cortex Stimulation using SJM EonC Stimulator

Sham stimulation

SHAM COMPARATOR

Device: Motor Cortex Stimulation using SJM EonC Stimulator

Interventions

Motor Cortex Stimulation using SJM EonC StimulatorDevice

Patients will be randomized to receive either active stimulation the first 3 months followed by a one-month washout, followed by Sham Stimulation the next 3 months, vs. the reverse order of treatment, followed by single blind stimulation, and an open label phase.

Active stimulationSham stimulation

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

Eligibility Criteria

Age21 Years - 70 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Men and women (non-pregnant) age 21-70 years;
Able to give informed consent in accordance with institutional policies;

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (1)

University of São Paulo - Hospital das Clínicas

São Paulo, Brazil

MeSH Terms

Conditions

NeuralgiaFacial Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Edward Karst
Abbott Neuromodulation
STUDY DIRECTOR

Enrollment

38 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

March 14, 2012

Study Start

October 2012

Date type not reported

This date has not been verified as actual or estimated.

Motor Cortex Stimulation for Chronic Neuropathic Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Active stimulation

Sham stimulation

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

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Active stimulation

Sham stimulation

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