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

NCT02030626 | Completed Phase 4

• 2 other identifiers: rTMS versus tDCS2010-018309-12
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Lumbar Radiculopathy

Keywords

Neuropathic pain; lumbar radiculopathy; rTMS; tDCS; placebo controlled study

Outcome Measures

Primary Outcomes (1)

• Comparison of rTMS and tDCS on average pain intensity

  Average pain intensity numerical scales (0-10)

  7 days after 3 days of stimulation

Secondary Outcomes (10)

• Comparison of rTMS and sham stimulation on average pain intensity

  7 days after 3 stimulation days

• comparison of tDCS and sham stimulation on average pain intensity

  at 7 days after 3 days of stimulation

• comparison of rTMS and tDCS on current pain

  1 hour after each stimulation session

• comparison of rTMS and tDCS on pain intensity

  2 days after 3 stimulation days

• comparison of rTMS versus tDCS and versus sham on BPI interference

  7 days after the end of 3 stimulation days

Study Arms (2)

active rTMS or active tDCS or placebo

EXPERIMENTAL

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

Sham rTMS followed by tDCS (or conversely)

PLACEBO COMPARATOR

Placebo rTMD followed by placebo tDCS or conversely

Device: active or placebo rTMS or active or placebo tDCS

Interventions

active or placebo rTMS or active or placebo tDCS DEVICE

Sham rTMS followed by tDCS (or conversely); active rTMS or active tDCS or placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (2)

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Henri Mondor, APHP

Créteil, 94000, France

Location

MeSH Terms

Conditions

Radiculopathy; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Didier BOUHASSIRA, MD PhD

  INSERM U 987

  STUDY DIRECTOR

• Jean Pascal LEFAUCHEUR, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 8, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

FR (2)