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

NCT ID: NCT02030626

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

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.

Conditions

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Lumbar Radiculopathy

Keywords

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Neuropathic pain lumbar radiculopathy rTMS tDCS placebo controlled study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

active or placebo rTMS or active or placebo tDCS

Intervention Type DEVICE

Sham rTMS followed by tDCS (or conversely)

Placebo rTMD followed by placebo tDCS or conversely

Group Type PLACEBO_COMPARATOR

active or placebo rTMS or active or placebo tDCS

Intervention Type DEVICE

Interventions

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active or placebo rTMS or active or placebo tDCS

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Ambroise Paré Paris

OTHER

Sponsor Role lead

Responsible Party

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Nadine ATTAL

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Didier BOUHASSIRA, MD PhD

Role: STUDY_DIRECTOR

INSERM U 987

Jean Pascal LEFAUCHEUR, MD PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Site Status

Hôpital Henri Mondor, APHP

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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2010-018309-12

Identifier Type: REGISTRY

Identifier Source: secondary_id

rTMS versus tDCS

Identifier Type: -

Identifier Source: org_study_id