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

Lumbar Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030626
• Other study ID #: rTMS versus tDCS
• Secondary ID: 2010-018309-12
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2014
• Last updated: December 8, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Neuralgia
• Radiculopathy

Intervention

Device:
• active or placebo rTMS or active or placebo tDCS

Locations

Country	Name	City	State
France	Hôpital Ambroise Paré	Boulogne Billancourt
France	Hôpital Henri Mondor, APHP	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of rTMS and tDCS on average pain intensity	Average pain intensity numerical scales (0-10)	7 days after 3 days of stimulation	No
Secondary	Comparison of rTMS and sham stimulation on average pain intensity	numerical scale for pain intensity (0-10)	7 days after 3 stimulation days	No
Secondary	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	No
Secondary	comparison of rTMS and tDCS on current pain	pain intensity (right now)1 hour after each stimulation	1 hour after each stimulation session	No
Secondary	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	No
Secondary	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	No
Secondary	comparison of rTMS versus tDCS and sham on pain catastrophizing	Pain catastrophizing scale (PCS)	7 days after the last day of stimulation (3 days)	No
Secondary	comparison of rTMS versus tDCS and sham on anxiety and depression	Hospital anxiety and depression scale	7 days after the end of stimulation sessions	No
Secondary	comparison of rTMS versus tDCS and sham on neuropathic symptoms	Neuropathic pain symptom inventory	7 days after the end of stimulations	No
Secondary	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	No
Secondary	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	Yes