Clinical trial NCT02030626: Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lumbar Radiculopathy
Keywords: Neuropathic pain
lumbar radiculopathy
rTMS
tDCS
placebo controlled study
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of rTMS and tDCS on average pain intensity
timeFrame: 7 days after 3 days of stimulation
Secondary outcomes:
measure: Comparison of rTMS and sham stimulation on average pain intensity
timeFrame: 7 days after 3 stimulation days
measure: comparison of tDCS and sham stimulation on average pain intensity
timeFrame: at 7 days after 3 days of stimulation
measure: comparison of rTMS and tDCS on current pain
timeFrame: 1 hour after each stimulation session
measure: comparison of rTMS and tDCS on pain intensity
timeFrame: 2 days after 3 stimulation days
measure: comparison of rTMS versus tDCS and versus sham on BPI interference
timeFrame: 7 days after the end of 3 stimulation days
measure: comparison of rTMS versus tDCS and sham on pain catastrophizing
timeFrame: 7 days after the last day of stimulation (3 days)
measure: comparison of rTMS versus tDCS and sham on anxiety and depression
timeFrame: 7 days after the end of stimulation sessions
measure: comparison of rTMS versus tDCS and sham on neuropathic symptoms
timeFrame: 7 days after the end of stimulations
measure: comparison of rTMS versus tDCS and sham on thermal testing
timeFrame: 2 days and 7 days after stimulation days
measure: comparison of safety between rTMS and tDCS and between neurostimulation and sham
timeFrame: immediately after each stimulation, then at 2 days and 7 days
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Créteil
country: France
facility: Hôpital Henri Mondor, APHP
Study officials:
affiliation: INSERM U 987
name: Didier BOUHASSIRA, MD PhD
role: STUDY_DIRECTOR
affiliation: APHP
name: Jean Pascal LEFAUCHEUR, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: