Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
ConditionChronic Neuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Grenoble
About this trial
The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:
* Classical rTMS stimulation * Deeper rTMS stimulation * Sham rTMS stimulation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient's written consent
Affiliated with social security system
Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
Patient whose analgesic treatment, is stable for at least 1 month.
Disqualifiers
History of drug addiction, epilepsy, cranial trauma
History of psychiatric disorder
Patients previously treated with rTMS
Patient with intracranial ferromagnetic material or implanted stimulator
Trial design
Design model
Parallel
Treatments tested in this trial
RepetitiveTranscranial Magnetic Stimulation (rTMS)
DeviceThe rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Classic rTMS Stimulation using the B65 CoilExperimental treatment 1 intervention
Group B: Deeper rTMS Stimulation using the B70 CoilExperimental treatment 1 intervention
Group C: control group with a sham stimulation using a sham coilSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evolution of Pain.
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).
Time frame
Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)Secondary outcomes
1
Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS
Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).
Time frame
Day 60 from the beginning of rTMS treatment compared to baseline.2
Rate of Responding Patients.
Comparison between the 3 groups of the rate of responding patients. Responding patients is defined by a 30% reduction in pain intensity assessed with VNS.
Time frame
week 7 compared with baseline3
Assessment of Overall Patient Improvement.
Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Time frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baseline4
Quality of Life Improvement.
Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire.SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Time frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baselineSponsors and contacts
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Source ClinicalTrials.gov