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NCT Number: NCT02386969

Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

About this study

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Central neuropathic pain
  • Chronic pain with an average pain intensity is greater than or equal to 40/100
  • Pain presents a daily or almost daily (at least 4 days out of 7)
  • Pain presents for more than 6 months
  • Patients who signed informed consent,
  • Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
  • Patients can be monitored for the duration of the study (29 weeks)
  • Patients affiliated to a health insurance plan or entitled,
  • Patients with a cerebral MRI T1.

Exclusion criteria

  • Labor dispute or Accident,
  • Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
  • Abuse of drugs or psychoactive substances
  • Peripheral Neuropathic Pain,
  • Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
  • Intermittent pain,
  • Pain in less than 6 months,
  • Presence of other pain more severe than that justify inclusion,
  • Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
  • Patients unable to understand informed consent, under guardianship,
  • Patients refusing to stop or can not stop the prohibited treatment during the study,
  • Patients participating in another research protocol involving a drug within 30 days before inclusion.

Treatment and study plan

active rTMS then sham rTMS

Device

A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months

sham rTMS then active rTMS

Device

A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months

Primary outcomes

  1. Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")

    Time frame: 3 weeks later the last session of rTMS (active ) so week n°12

    Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

  2. Percentage of pain relief (0%= " no pain relief " and 100% " complete pain

    Time frame: 3 weeks later the last session of rTMS (sham) so week n°29.

    Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

Secondary outcomes

  1. Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").

    Time frame: 3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.

  2. Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

    Time frame: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

  3. Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

    Time frame: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

  4. Neuropathic dimension

    Time frame: at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)

    specific paper questionnaire of neuropathic pain NPSI at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)

  5. - Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.

    Time frame: at the end of each period of 4 sessions (weeks n°12 and 29)

  6. Consumption of analgesic treatment

    Time frame: 3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2015
Registry last updated
Apr 26, 2021

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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