rTMS Efficacy Coupled With Mirror Therapy

Neuropathic Pain Clinical Trial

— STIRM  

Official title:

Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867187
• Other study ID #: 21CH035
• Secondary ID: 2021-A00720-41
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Roland Peyron, MDPHD
• Phone: (0)477825684
• Email: roland.peyron[@]univ-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Repetitive transcranial magnetic stimulation (rTMS)
20 minutes of high frequency (20Hz) rTMS.
• Mirror therapy using virtual reality
active mirror-based therapy
• Mirror therapy using sham mirror
20 minutes of sham mirror-based therapy

Locations

Country	Name	City	State
France	Hôpital Neurologique Pierre Wertheimer	Bron
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Week 9
Secondary	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	week 12
Secondary	Spontaneous brain activity	Functional MRI at rest	week 12
Secondary	neuropathic dimension	overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain)	Week 3, 5, 7, 9,12
Secondary	Adverse events	Nature and number of adverse events	Week 3, 5, 7, 9,12