Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain

Study Overview
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Brief Summary
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The present study aims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.

Detailed Description
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The present study ims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation (rTMS) and transcranial direct electrical current (tDCS) of the motor cortex in patients with chronic lumbar radiculopathy on average pain intensity. This will be a sham controlled crossover design : patients will be randomized to receive either active rTMS or tDCS during 3 consecutive days followed by the alternative treatment within 3 weeks apart, or sham rTMS or tDCS during 3 consecutive dats followed by the alternative treatment within 3 weeks apart. The investigator will be blind to the treatment. Assessments will be performed before each treatment, then 1 hour after the end of the third day session, then 2 days and 1 week after the stimulation. Assessments will include pain questionnaires, quality of life, anxiety and depression, catastrophizing and evaluation of treatment effect on experimental pain using Quantitative sensory testing.

Official Title
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Comparison of the Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation of the Motor Cortex in Patients With Neuropathic Pain Due to Chronic Radiculopathy

Conditions
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Lumbar Radiculopathy

Intervention / Treatment
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* Device: active or placebo rTMS or active or placebo tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged more than 18 years and less than 60 years, males of females Lumbosciatica or lumbocruralgia with predominant neuropathic components with DN4 score ≥ 4/10 Chronic pain with an intensity of at least 4/10 Stable analgesic treatment for at least 15 days before inclusion Able to speak and understand French Social security Exclusion Criteria: Work accident or litigation Contraindication to rTMS (sismotherapy in the preceding month, epilepsia, past head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy or lactation Major depressive episode Intermittent pain Consent refusal Impossible to follow up during the duration of the study Pain more severe than neuropathic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active rTMS or active tDCS or placebo<br>Active rTMS (10 Hz) of the motor cortex followed by active tDCS (2 mA) of the motor cortex or conversely | Device: active or placebo rTMS or active or placebo tDCS<br> <br> |
| Placebo Comparator: Sham rTMS followed by tDCS (or conversely)<br>Placebo rTMD followed by placebo tDCS or conversely | Device: active or placebo rTMS or active or placebo tDCS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of rTMS and tDCS on average pain intensity | Average pain intensity numerical scales (0-10) | 7 days after 3 days of stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of rTMS and sham stimulation on average pain intensity | numerical scale for pain intensity (0-10) | 7 days after 3 stimulation days | 
| comparison of tDCS and sham stimulation on average pain intensity | numerical scales for pain intensity (0-10) | at 7 days after 3 days of stimulation | 
| comparison of rTMS and tDCS on current pain | pain intensity (right now)1 hour after each stimulation | 1 hour after each stimulation session | 
| comparison of rTMS and tDCS on pain intensity | numerical score (0-10) for pain over the last 24 hours | 2 days after 3 stimulation days | 
| comparison of rTMS versus tDCS and versus sham on BPI interference | BPI interference scale (0-70) | 7 days after the end of 3 stimulation days | 
| comparison of rTMS versus tDCS and sham on pain catastrophizing | Pain catastrophizing scale (PCS) | 7 days after the last day of stimulation (3 days) | 
| comparison of rTMS versus tDCS and sham on anxiety and depression | Hospital anxiety and depression scale | 7 days after the end of stimulation sessions | 
| comparison of rTMS versus tDCS and sham on neuropathic symptoms | Neuropathic pain symptom inventory | 7 days after the end of stimulations | 
| comparison of rTMS versus tDCS and sham on thermal testing | thermal testing using thermotest on the upper limbs | 2 days and 7 days after stimulation days | 
| comparison of safety between rTMS and tDCS and between neurostimulation and sham | any emerging side effects | immediately after each stimulation, then at 2 days and 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, lumbar radiculopathy, rTMS, tDCS, placebo controlled study