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Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

active rTMS then sham rTMS

sham rTMS then active rTMS

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, repetitive transcranial magnetic stimulation (rTMS)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Central neuropathic pain
Chronic pain with an average pain intensity is greater than or equal to 40/100
Pain presents a daily or almost daily (at least 4 days out of 7)
Pain presents for more than 6 months
Patients who signed informed consent,
Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
Patients can be monitored for the duration of the study (29 weeks)
Patients affiliated to a health insurance plan or entitled,
Patients with a cerebral MRI T1.

Exclusion Criteria:

Labor dispute or Accident,
Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
Abuse of drugs or psychoactive substances
Peripheral Neuropathic Pain,
Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
Intermittent pain,
Pain in less than 6 months,
Presence of other pain more severe than that justify inclusion,
Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
Patients unable to understand informed consent, under guardianship,
Patients refusing to stop or can not stop the prohibited treatment during the study,
Patients participating in another research protocol involving a drug within 30 days before inclusion.

Sites / Locations

Chu Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Active rTMS then sham rTMS

Sham rTMS then active rTMS

Arm Description

Active rTMS in 1st period and sham rTMS in 2nd period

Sham rTMS in 1st period and active rTMS in 2nd period

Outcomes

Primary Outcome Measures

Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")

Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

Percentage of pain relief (0%= " no pain relief " and 100% " complete pain

Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

Secondary Outcome Measures

Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").

Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

Neuropathic dimension

specific paper questionnaire of neuropathic pain NPSI at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)

- Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.

Consumption of analgesic treatment

Full Information

NCT ID

NCT02386969

First Posted

March 5, 2015

Last Updated

April 23, 2021

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT02386969

Brief Title

Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

Official Title

Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 11, 2015 (Actual)

Primary Completion Date

March 29, 2018 (Actual)

Study Completion Date

September 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

Detailed Description

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.

6. Conditions and Keywords

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

Neuropathic Pain

Keywords

Neuropathic Pain, repetitive transcranial magnetic stimulation (rTMS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS then sham rTMS

Arm Type

Experimental

Arm Description

Active rTMS in 1st period and sham rTMS in 2nd period

Arm Title

Sham rTMS then active rTMS

Arm Type

Experimental

Arm Description

Sham rTMS in 1st period and active rTMS in 2nd period

Intervention Type

Device

Intervention Name(s)

active rTMS then sham rTMS

Intervention Description

A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months

Intervention Type

Device

Intervention Name(s)

sham rTMS then active rTMS

Intervention Description

A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months

Primary Outcome Measure Information:

Title

Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")

Description

Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

Time Frame

3 weeks later the last session of rTMS (active ) so week n°12

Title

Percentage of pain relief (0%= " no pain relief " and 100% " complete pain

Description

Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

Time Frame

3 weeks later the last session of rTMS (sham) so week n°29.

Secondary Outcome Measure Information:

Title

Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").

Time Frame

3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.

Title

Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

Time Frame

before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

Title

Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

Time Frame

before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

Title

Neuropathic dimension

Description

specific paper questionnaire of neuropathic pain NPSI at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)

Time Frame

at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)

Title

- Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.

Time Frame

at the end of each period of 4 sessions (weeks n°12 and 29)

Title

Consumption of analgesic treatment

Time Frame

3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Central neuropathic pain Chronic pain with an average pain intensity is greater than or equal to 40/100 Pain presents a daily or almost daily (at least 4 days out of 7) Pain presents for more than 6 months Patients who signed informed consent, Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study, Patients can be monitored for the duration of the study (29 weeks) Patients affiliated to a health insurance plan or entitled, Patients with a cerebral MRI T1. Exclusion Criteria: Labor dispute or Accident, Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women) Abuse of drugs or psychoactive substances Peripheral Neuropathic Pain, Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease) Intermittent pain, Pain in less than 6 months, Presence of other pain more severe than that justify inclusion, Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session) Patients unable to understand informed consent, under guardianship, Patients refusing to stop or can not stop the prohibited treatment during the study, Patients participating in another research protocol involving a drug within 30 days before inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roland PEYRON, MD PhD

Organizational Affiliation

CHU de Saint-Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu Saint-Etienne

City

Saint-etienne

ZIP/Postal Code

42055

Country

France

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

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