Motor Threshold and Motor Cortex Stimulation

NCT02255643 | Completed

• 1 other identifier: H14-01258
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest. The strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control. The aim of this study is to analyze the optimal stimulation parameters in patients already implanted with a motor cortex stimulation who have received good pain relief. The actual voltage may vary widely between patients but the investigators feel that there may be an "ideal" voltage if it is measured as a percentage of motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle contraction then a PMT = 80% would be a voltage that was eighty percent of that value. Although the actual voltage may be widely different between patients, the percentage needed may be very similar. The investigators therefore plan to measure the effect of different percentages of PMT in patients already being treated with motor cortex stimulation. Systematic analysis of the findings of this study might help the individual participant and future patients to better programming and less side effects.

Conditions

Neuropathic Pain

Keywords

motor cortex stimulation; chronic neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain measured on the Visual Analogue Scale with different PMT Settings

  at the End of each trial period, typically 14 days after changes in PMT Settings

Secondary Outcomes (1)

• Quality of Life assessment with the SF-36 questionnaire

  at the end of each trial period, typically at 14 days

Other Outcomes (1)

• Pain assessment with the McGill pain questionnaire to record impact of pain

  at the end of each trial period, typically 14 days

Study Arms (3)

-10% of effective PMT

EXPERIMENTAL

Patients are set to a voltage 10% less than their original PMT at start of study, Changes in PMT settings

Device: Change of PMT setting

former setting (+/- 0% of PMT)

ACTIVE COMPARATOR

Patients are set to their original PMT at start of study, Changes in PMT settings

Device: Change of PMT setting

+10% of effective PMT

EXPERIMENTAL

Patients are set to a voltage 10% more than their original PMT at start of study, Changes in PMT settings

Device: Change of PMT setting

Interventions

Change of PMT setting DEVICE

The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)

+10% of effective PMT; -10% of effective PMT; former setting (+/- 0% of PMT)

Eligibility Criteria

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

You may qualify if:

• Adult patient more than 18 years of age
• Chronic neuropathic pain effectively treated with motor cortex stimulation
• Stable medication during the trial
• Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.

You may not qualify if:

• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
• Technical malfunction of the MCS device
• History of seizures
• Unable to provide informed consent

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

Location

Related Publications (4)

• Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x.

  PMID: 1705329 BACKGROUND

• Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37.

  PMID: 1792954 BACKGROUND

• Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V.

  PMID: 8657427 BACKGROUND

• Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.

  PMID: 18541887 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher R Honey, MD, DPhil

  UBC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 2, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

CA (1)