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

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
active or placebo rTMS or active or placebo tDCS
Sponsored by
Hospital Ambroise Paré Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Neuropathic pain, lumbar radiculopathy, rTMS, tDCS, placebo controlled study

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Ambroise Paré
  • Hôpital Henri Mondor, APHP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active rTMS or active tDCS or placebo

Sham rTMS followed by tDCS (or conversely)

Arm Description

Active rTMS (10 Hz) of the motor cortex followed by active tDCS (2 mA) of the motor cortex or conversely

Placebo rTMD followed by placebo tDCS or conversely

Outcomes

Primary Outcome Measures

Comparison of rTMS and tDCS on average pain intensity
Average pain intensity numerical scales (0-10)

Secondary Outcome Measures

Comparison of rTMS and sham stimulation on average pain intensity
numerical scale for pain intensity (0-10)
comparison of tDCS and sham stimulation on average pain intensity
numerical scales for pain intensity (0-10)
comparison of rTMS and tDCS on current pain
pain intensity (right now)1 hour after each stimulation
comparison of rTMS and tDCS on pain intensity
numerical score (0-10) for pain over the last 24 hours
comparison of rTMS versus tDCS and versus sham on BPI interference
BPI interference scale (0-70)
comparison of rTMS versus tDCS and sham on pain catastrophizing
Pain catastrophizing scale (PCS)
comparison of rTMS versus tDCS and sham on anxiety and depression
Hospital anxiety and depression scale
comparison of rTMS versus tDCS and sham on neuropathic symptoms
Neuropathic pain symptom inventory
comparison of rTMS versus tDCS and sham on thermal testing
thermal testing using thermotest on the upper limbs
comparison of safety between rTMS and tDCS and between neurostimulation and sham
any emerging side effects

Full Information

First Posted
January 7, 2014
Last Updated
December 8, 2015
Sponsor
Hospital Ambroise Paré Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02030626
Brief Title
Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Ambroise Paré Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Neuropathic pain, lumbar radiculopathy, rTMS, tDCS, placebo controlled study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rTMS or active tDCS or placebo
Arm Type
Experimental
Arm Description
Active rTMS (10 Hz) of the motor cortex followed by active tDCS (2 mA) of the motor cortex or conversely
Arm Title
Sham rTMS followed by tDCS (or conversely)
Arm Type
Placebo Comparator
Arm Description
Placebo rTMD followed by placebo tDCS or conversely
Intervention Type
Device
Intervention Name(s)
active or placebo rTMS or active or placebo tDCS
Primary Outcome Measure Information:
Title
Comparison of rTMS and tDCS on average pain intensity
Description
Average pain intensity numerical scales (0-10)
Time Frame
7 days after 3 days of stimulation
Secondary Outcome Measure Information:
Title
Comparison of rTMS and sham stimulation on average pain intensity
Description
numerical scale for pain intensity (0-10)
Time Frame
7 days after 3 stimulation days
Title
comparison of tDCS and sham stimulation on average pain intensity
Description
numerical scales for pain intensity (0-10)
Time Frame
at 7 days after 3 days of stimulation
Title
comparison of rTMS and tDCS on current pain
Description
pain intensity (right now)1 hour after each stimulation
Time Frame
1 hour after each stimulation session
Title
comparison of rTMS and tDCS on pain intensity
Description
numerical score (0-10) for pain over the last 24 hours
Time Frame
2 days after 3 stimulation days
Title
comparison of rTMS versus tDCS and versus sham on BPI interference
Description
BPI interference scale (0-70)
Time Frame
7 days after the end of 3 stimulation days
Title
comparison of rTMS versus tDCS and sham on pain catastrophizing
Description
Pain catastrophizing scale (PCS)
Time Frame
7 days after the last day of stimulation (3 days)
Title
comparison of rTMS versus tDCS and sham on anxiety and depression
Description
Hospital anxiety and depression scale
Time Frame
7 days after the end of stimulation sessions
Title
comparison of rTMS versus tDCS and sham on neuropathic symptoms
Description
Neuropathic pain symptom inventory
Time Frame
7 days after the end of stimulations
Title
comparison of rTMS versus tDCS and sham on thermal testing
Description
thermal testing using thermotest on the upper limbs
Time Frame
2 days and 7 days after stimulation days
Title
comparison of safety between rTMS and tDCS and between neurostimulation and sham
Description
any emerging side effects
Time Frame
immediately after each stimulation, then at 2 days and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier BOUHASSIRA, MD PhD
Organizational Affiliation
INSERM U 987
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean Pascal LEFAUCHEUR, MD PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Ambroise Paré
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Hôpital Henri Mondor, APHP
City
Créteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

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

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