Neuropathic Pain
Conditions
Keywords
transcranial magnetic stimulation, virtual reality, mirror therapy, brain networks, predictive model
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.
Interventions
OTHERRepetitive transcranial magnetic stimulation (rTMS)
20 minutes of high frequency (20Hz) rTMS.
OTHERMirror therapy using virtual reality
active mirror-based therapy
OTHERMirror therapy using sham mirror
20 minutes of sham mirror-based therapy
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measurement | Week 9 | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life after treatment | week 12 | EQ5D scale (min = 0 worst imaginable health condition and max = 100 best health condition imaginable) and Analgesic consumption of Appeal |
| Spontaneous brain activity | week 12 | Functional MRI at rest |
| neuropathic dimension | Week 3, 5, 7, 9,12 | overall score of the neuropathic pain symptoms inventory (NPSI) (min = 0 no neuropathic pain and max = 100 intensive neuropathic pain) |
| Adverse events | Week 3, 5, 7, 9,12 | Nature and number of adverse events |
Countries
France
Contacts
CONTACTRoland Peyron, MDPHD
CONTACTBeatrice DEYGAS, CRA
PRINCIPAL_INVESTIGATORRoland Peyron, MDPHD
CENTRE HOSPITALIER DE SAINT-ETIENNE
Outcome results
None listed