Cyclization of Motor Cortex Stimulation

NCT02465918 | Completed

• 1 other identifier: H15-01420
• Study Type: interventional
• Target: 6
• 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 timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings

  At the End of each trial period, typically 14 days after change in stimulation settings

Secondary Outcomes (1)

• Quality of Life assessment with the SF-36 questionnaire

  At the end of each trial period, typically at 14 days after change in stimulation settings

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 after change in stimulation setting

Study Arms (4)

Original Setting- MCS 30 min off/0 min off

ACTIVE COMPARATOR

Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour.

Device: motor cortex stimulation (Change of Stimulation Timing)

MCS 25 min on/5 min off

EXPERIMENTAL

Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour.

Device: motor cortex stimulation (Change of Stimulation Timing)

MCS 20 min on/10 min off

EXPERIMENTAL

Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour.

Device: motor cortex stimulation (Change of Stimulation Timing)

MCS 15 min on/15 min off

EXPERIMENTAL

Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour.

Device: motor cortex stimulation (Change of Stimulation Timing)

Interventions

motor cortex stimulation (Change of Stimulation Timing) DEVICE

MCS 15 min on/15 min off; MCS 20 min on/10 min off; MCS 25 min on/5 min off; Original Setting- MCS 30 min off/0 min off

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)

The 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Neurosurgeon

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

CA (1)