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Completed

NCT Number: NCT02030626

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Ambroise Paré, Boulogne-Billancourt, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active or placebo rTMS or active or placebo tDCS

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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