A Phase 4 interventional study of active or placebo rTMS or active or placebo tDCS in Lumbar Radiculopathy, sponsored by Hospital Ambroise Paré Paris. Completed at 2 sites in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-09.
Sponsored by Hospital Ambroise Paré Paris · Phase 4, Interventional, and Treatment
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.
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.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 35 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Hospital Ambroise Paré Paris is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
Placebo rTMD followed by placebo tDCS or conversely
Device: active or placebo rTMS or active or placebo tDCS
Comparison of rTMS and tDCS on average pain intensity
Average pain intensity numerical scales (0-10)
Time frame: 7 days after 3 days of stimulation
Comparison of rTMS and sham stimulation on average pain intensity
numerical scale for pain intensity (0-10)
Time frame: 7 days after 3 stimulation days
comparison of tDCS and sham stimulation on average pain intensity
numerical scales for pain intensity (0-10)
Time frame: 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
Time frame: 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
Time frame: 2 days after 3 stimulation days
comparison of rTMS versus tDCS and versus sham on BPI interference
BPI interference scale (0-70)
Time frame: 7 days after the end of 3 stimulation days
comparison of rTMS versus tDCS and sham on pain catastrophizing
Pain catastrophizing scale (PCS)
Time frame: 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
Time frame: 7 days after the end of stimulation sessions
comparison of rTMS versus tDCS and sham on neuropathic symptoms
Neuropathic pain symptom inventory
Time frame: 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
Time frame: 2 days and 7 days after stimulation days
comparison of safety between rTMS and tDCS and between neurostimulation and sham
any emerging side effects
Time frame: immediately after each stimulation, then at 2 days and 7 days
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Ambroise Paré Paris