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Cyclization of Motor Cortex Stimulation

NCT ID: NCT02465918

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Original Setting- MCS 30 min off/0 min off

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

Group Type ACTIVE_COMPARATOR

motor cortex stimulation (Change of Stimulation Timing)

Intervention Type DEVICE

MCS 25 min on/5 min off

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

Group Type EXPERIMENTAL

motor cortex stimulation (Change of Stimulation Timing)

Intervention Type DEVICE

MCS 20 min on/10 min off

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

Group Type EXPERIMENTAL

motor cortex stimulation (Change of Stimulation Timing)

Intervention Type DEVICE

MCS 15 min on/15 min off

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

Group Type EXPERIMENTAL

motor cortex stimulation (Change of Stimulation Timing)

Intervention Type DEVICE

Interventions

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motor cortex stimulation (Change of Stimulation Timing)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Christopher Honey

Associate Professor/Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 1705329 (View on PubMed)

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.

Reference Type RESULT
PMID: 1792954 (View on PubMed)

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.

Reference Type RESULT
PMID: 8657427 (View on PubMed)

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.

Reference Type RESULT
PMID: 18541887 (View on PubMed)

Other Identifiers

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H15-01420

Identifier Type: -

Identifier Source: org_study_id