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rTMS Efficacy Coupled With Mirror Therapy (STIRM)

Primary Purpose

Neuropathic Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation (rTMS)
Mirror therapy using virtual reality
Mirror therapy using sham mirror
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring transcranial magnetic stimulation, virtual reality, mirror therapy, brain networks, predictive model

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical symptoms typical of neuropathic pain
  • Refractory to drug therapies
  • Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
  • Having right to health benefits

Exclusion Criteria:

  • Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
  • Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
  • Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).

Sites / Locations

  • Hôpital Neurologique Pierre Wertheimer
  • Centre Hospitalier Universitaire de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS active and active mirror-based therapy using virtual reality

rTMS active and sham mirror-based therapy using virtual reality

Arm Description

The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality.

The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality.

Outcomes

Primary Outcome Measures

Pain intensity measurement
Averages of the daily visual analogue scale scores (min no pain max pain imaginable) measured during the first week (Week 1) and that measured during the week following the last session (week 9)

Secondary Outcome Measures

Quality of life after treatment
EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal
Spontaneous brain activity
Functional MRI at rest
neuropathic dimension
overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain)
Adverse events
Nature and number of adverse events

Full Information

First Posted
April 27, 2021
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04867187
Brief Title
rTMS Efficacy Coupled With Mirror Therapy
Acronym
STIRM
Official Title
Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.
Detailed Description
This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect. Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity. It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
transcranial magnetic stimulation, virtual reality, mirror therapy, brain networks, predictive model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: patient with 4 sessions of active mirror therapy followed by an rTMS stimulation session of the primary motor cortex (M1), Group 2: patient with 4 sessions of sham mirror therapy followed by rTMS of the primary motor cortex (M1).
Masking
ParticipantInvestigator
Masking Description
The (motor) task performed by the patient during the sham control mirror therapy session is identical to that performed in active mirror therapy. The only difference is that in sham mirror therapy there is no optical illusion of movement of the affected hand.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS active and active mirror-based therapy using virtual reality
Arm Type
Experimental
Arm Description
The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and active mirror-based therapy using virtual reality.
Arm Title
rTMS active and sham mirror-based therapy using virtual reality
Arm Type
Sham Comparator
Arm Description
The patient will have an amount of 4 sessions (S3, S5, S7 and S9) for 1.5 months: 1 session every 2 weeks. The patient will receive rTMS active and sham mirror-based therapy using virtual reality.
Intervention Type
Other
Intervention Name(s)
Repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
20 minutes of high frequency (20Hz) rTMS.
Intervention Type
Other
Intervention Name(s)
Mirror therapy using virtual reality
Intervention Description
active mirror-based therapy
Intervention Type
Other
Intervention Name(s)
Mirror therapy using sham mirror
Intervention Description
20 minutes of sham mirror-based therapy
Primary Outcome Measure Information:
Title
Pain intensity measurement
Description
Averages of the daily visual analogue scale scores (min no pain max pain imaginable) measured during the first week (Week 1) and that measured during the week following the last session (week 9)
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
Quality of life after treatment
Description
EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal
Time Frame
week 12
Title
Spontaneous brain activity
Description
Functional MRI at rest
Time Frame
week 12
Title
neuropathic dimension
Description
overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain)
Time Frame
Week 3, 5, 7, 9,12
Title
Adverse events
Description
Nature and number of adverse events
Time Frame
Week 3, 5, 7, 9,12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical symptoms typical of neuropathic pain Refractory to drug therapies Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least Having right to health benefits Exclusion Criteria: Ferromagnetic components and implanted microprocessors (i.e. cochlear implants) Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment. Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roland Peyron, MDPHD
Phone
(0)477825684
Ext
+33
Email
roland.peyron@univ-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice DEYGAS, CRA
Email
beatrice.deygas@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Peyron, MDPHD
Organizational Affiliation
CENTRE HOSPITALIER DE SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Neurologique Pierre Wertheimer
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Garcia-Larrea, MD
Phone
0)472118866
Ext
+33
Email
luis-jose.garcia-larrea@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Patrick MERTENS, MD PhD
First Name & Middle Initial & Last Name & Degree
Nathalie ANDRE-OBADIA, MD
First Name & Middle Initial & Last Name & Degree
Luis GARCIA- LARREA, MD
Facility Name
Centre Hospitalier Universitaire de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland PEYRON, MD PHD
Phone
(0)477825684
Ext
+33
Email
roland.peyron@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Christelle Créac'h, MD
First Name & Middle Initial & Last Name & Degree
Roland PEYRON, MD PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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rTMS Efficacy Coupled With Mirror Therapy

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