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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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ClinicalTrials.gov Identifier: NCT02030626
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Nadine ATTAL, Hospital Ambroise Paré Paris

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.

Condition or disease Intervention/treatment Phase
Lumbar Radiculopathy Device: active or placebo rTMS or active or placebo tDCS Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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



Primary Outcome Measures :
  1. Comparison of rTMS and tDCS on average pain intensity [ Time Frame: 7 days after 3 days of stimulation ]
    Average pain intensity numerical scales (0-10)


Secondary Outcome Measures :
  1. Comparison of rTMS and sham stimulation on average pain intensity [ Time Frame: 7 days after 3 stimulation days ]
    numerical scale for pain intensity (0-10)

  2. comparison of tDCS and sham stimulation on average pain intensity [ Time Frame: at 7 days after 3 days of stimulation ]
    numerical scales for pain intensity (0-10)

  3. comparison of rTMS and tDCS on current pain [ Time Frame: 1 hour after each stimulation session ]
    pain intensity (right now)1 hour after each stimulation

  4. comparison of rTMS and tDCS on pain intensity [ Time Frame: 2 days after 3 stimulation days ]
    numerical score (0-10) for pain over the last 24 hours

  5. comparison of rTMS versus tDCS and versus sham on BPI interference [ Time Frame: 7 days after the end of 3 stimulation days ]
    BPI interference scale (0-70)

  6. comparison of rTMS versus tDCS and sham on pain catastrophizing [ Time Frame: 7 days after the last day of stimulation (3 days) ]
    Pain catastrophizing scale (PCS)

  7. comparison of rTMS versus tDCS and sham on anxiety and depression [ Time Frame: 7 days after the end of stimulation sessions ]
    Hospital anxiety and depression scale

  8. comparison of rTMS versus tDCS and sham on neuropathic symptoms [ Time Frame: 7 days after the end of stimulations ]
    Neuropathic pain symptom inventory

  9. comparison of rTMS versus tDCS and sham on thermal testing [ Time Frame: 2 days and 7 days after stimulation days ]
    thermal testing using thermotest on the upper limbs

  10. comparison of safety between rTMS and tDCS and between neurostimulation and sham [ Time Frame: immediately after each stimulation, then at 2 days and 7 days ]
    any emerging side effects



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030626


Locations
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France
Hôpital Ambroise Paré
Boulogne Billancourt, France, 92100
Hôpital Henri Mondor, APHP
Créteil, France, 94000
Sponsors and Collaborators
Hospital Ambroise Paré Paris
Investigators
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Study Director: Didier BOUHASSIRA, MD PhD INSERM U 987
Principal Investigator: Jean Pascal LEFAUCHEUR, MD PhD APHP
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Responsible Party: Nadine ATTAL, MD PhD, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier: NCT02030626    
Other Study ID Numbers: rTMS versus tDCS
2010-018309-12 ( Registry Identifier: eudract )
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Nadine ATTAL, Hospital Ambroise Paré Paris:
Neuropathic pain
lumbar radiculopathy
rTMS
tDCS
placebo controlled study
Additional relevant MeSH terms:
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Neuralgia
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations