rTMS Efficacy Coupled With Mirror Therapy (STIRM)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Neuropathic Pain

Treatments: Other: Mirror therapy using virtual reality; Other: Mirror therapy using sham mirror; Other: Repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04867187

2021-A00720-41 (Other Identifier)

21CH035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

rTMS active and active mirror-based therapy using virtual reality

Experimental group

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.

Treatment:

Other: Repetitive transcranial magnetic stimulation (rTMS)

Other: Mirror therapy using virtual reality

rTMS active and sham mirror-based therapy using virtual reality

Sham Comparator group

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.

Treatment:

Other: Repetitive transcranial magnetic stimulation (rTMS)

Other: Mirror therapy using sham mirror