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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Device: active or placebo rTMS or active or placebo tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Boulogne Billancourt, France, 92100
    • Hôpital Ambroise Paré
  • Créteil, France, 94000
    • Hopital Henri MONDOR, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active rTMS or active tDCS or placebo; 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 Comparator: Sham rTMS followed by tDCS (or conversely); Placebo rTMD followed by placebo tDCS or conversely	Device: active or placebo rTMS or active or placebo tDCS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Ambroise Paré Paris
• Investigators: Study Director: Didier BOUHASSIRA, MD PhD, INSERM U 987; Principal Investigator: Jean Pascal LEFAUCHEUR, MD PhD, APHP

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: tDCS; Neuropathic pain; rTMS; lumbar radiculopathy; placebo controlled study
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Radiculopathy
• Other Study ID Numbers: rTMS versus tDCS; 2010-018309-12 (Registry Identifier: eudract)