The Efficacy of Motor Cortex Stimulation for Pain Control

NCT00462566 | Completed

• 1 other identifier: CDHA004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to determine if motor cortex stimulation works for the following conditions:

1. 1.Deafferentation facial pain,
2. 2.Upper extremity complex regional pain syndrome (CRPS) and
3. 3.Brachial plexus avulsion or phantom limb pain.

Conditions

Neuropathic Pain; Phantom Limb Pain; Stump Pain; Brachial Plexus Avulsion; Deafferentation Pain; Facial Pain; Complex Regional Pain Syndrome

Keywords

Motor cortex stimulation; neuropathic; pain; complex regional pain syndrome; deafferentation facial pain

Outcome Measures

Primary Outcomes (7)

• Visual Analog scale

  1 month preop, at 12 and 24 weeks postop

• SF-36

  1 month preop, at 12 and 24 weeks postop

• McGill Pain questionnaire

  1 month preop, at 12 and 24 weeks postop

• Beck II depression

  1 month preop, at 12 and 24 weeks postop

• Global impression of change

  at 12 and 24 weeks postop

• Medications log

  1 month preop, at 12 and 24 weeks postop

• Employment status

  1 month preop, at 12 and 24 weeks postop

Interventions

motor cortex stimulation DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis in one of the following three categories:
• Unilateral upper extremity neuropathic pain such as phantom limb pain, stump pain or brachial plexus avulsion
• Neuropathic deafferentation facial pain
• Upper extremity complex regional pain syndrome (CRPS)
• Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
• Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
• Patients who are willing to provide informed consent.

You may not qualify if:

• Patients who are not considered medically fit for neurosurgery.
• Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
• Patients who are not able to provide informed consent.
• Patients unable to have magnetic resonance imaging (MRI).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (1)

• Radic JA, Beauprie I, Chiasson P, Kiss ZH, Brownstone RM. Motor Cortex Stimulation for Neuropathic Pain: A Randomized Cross-over Trial. Can J Neurol Sci. 2015 Nov;42(6):401-9. doi: 10.1017/cjn.2015.292. Epub 2015 Sep 1.

  PMID: 26324857 RESULT

MeSH Terms

Conditions

Neuralgia; Phantom Limb; Causalgia; Facial Pain; Complex Regional Pain Syndromes; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Autonomic Nervous System Diseases

Study Officials

• Robert M Brownstone, MD, PhD

  Dalhousie University, Queen Elizabeth II Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 19, 2007
• Study Start: October 1, 2005
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 18, 2016

Record last verified: 2016-06

Locations

CA (1)