Health TrialsbyHealthPanel

rTMS Efficacy Coupled With Mirror Therapy

ConditionNeuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Repetitive transcranial magnetic stimulation (rTMS)

    Other intervention

    20 minutes of high frequency (20Hz) rTMS.

  • Mirror therapy using virtual reality

    Other intervention

    active mirror-based therapy

  • Mirror therapy using sham mirror

    Other intervention

    20 minutes of sham mirror-based therapy

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: rTMS active and active mirror-based therapy using virtual realityExperimental treatment 2 interventions
Group B: rTMS active and sham mirror-based therapy using virtual realitySham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Week 9

Secondary outcomes

1

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

Time frame
week 12
2

Spontaneous brain activity

Functional MRI at rest

Time frame
week 12
3

neuropathic dimension

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
4

Adverse events

Nature and number of adverse events

Time frame
Week 3, 5, 7, 9,12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Source ClinicalTrials.gov
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