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Cyclization of Motor Cortex Stimulation

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

motor cortex stimulation (Change of Stimulation Timing)

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Original Setting- MCS 30 min off/0 min off

MCS 25 min on/5 min off

MCS 20 min on/10 min off

MCS 15 min on/15 min off

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life assessment with the SF-36 questionnaire

Full Information

NCT ID

NCT02465918

First Posted

June 4, 2015

Last Updated

October 29, 2020

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02465918

Brief Title

Cyclization of Motor Cortex Stimulation

Official Title

The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Original Setting- MCS 30 min off/0 min off

Arm Type

Active Comparator

Arm Description

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

Arm Title

MCS 25 min on/5 min off

Arm Type

Experimental

Arm Description

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

Arm Title

MCS 20 min on/10 min off

Arm Type

Experimental

Arm Description

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

Arm Title

MCS 15 min on/15 min off

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

motor cortex stimulation (Change of Stimulation Timing)

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Quality of Life assessment with the SF-36 questionnaire

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

The Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E3

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

1705329

Citation

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.

Results Reference

result

PubMed Identifier

1792954

Citation

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.

Results Reference

result

PubMed Identifier

8657427

Citation

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.

Results Reference

result

PubMed Identifier

18541887

Citation

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.

Results Reference

result

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Cyclization of Motor Cortex Stimulation

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