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NCT Number: NCT04936646

Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain:

* Classical rTMS stimulation * Deeper rTMS stimulation * Sham rTMS stimulation

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Key information

Conditions

Chronic Neuropathic Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de la douleur, CHU Grenoble Alpes

Grenoble, Isère, 38043, France

Location status: Recruiting

Location contact

HODAj Hasan, MD

CONTACT

About this study

Conduct of study:

  • Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient.
  • Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week.
  • Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks.
  • After the end of neurostimulation sessions, patients will be followed for 2 weeks.
  • Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient's written consent
  • Affiliated with social security system
  • Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
  • Patient whose analgesic treatment, is stable for at least 1 month.
  • Patient not responding to conventional treatments
  • Prescreening EVN >3

Exclusion criteria

  • History of drug addiction, epilepsy, cranial trauma
  • History of psychiatric disorder
  • Patients previously treated with rTMS
  • Patient with intracranial ferromagnetic material or implanted stimulator
  • New treatment for less than one month
  • Pregnant or Breastfeeding woman
  • Patient who does not understand the study protocol
  • Persons who are protected under the act.

Treatment and study plan

RepetitiveTranscranial Magnetic Stimulation (rTMS)

Device

The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.

Primary outcomes

  1. Evolution of Pain.

    Time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)

    Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).

Secondary outcomes

  1. Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS

    Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.

    Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).

  2. Rate of Responding Patients.

    Time frame: week 7 compared with baseline

    Comparison between the 3 groups of the rate of responding patients. Responding patients is defined by a 30% reduction in pain intensity assessed with VNS.

  3. Assessment of Overall Patient Improvement.

    Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline

    Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).

  4. Quality of Life Improvement.

    Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline

    Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire.SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.

  5. Evolution of Anxiety and Depressive Traits.

    Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline

    Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.

  6. Evolution of Symptomatological Profiles of Neuropathic Pain.

    Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.

    Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).

  7. Sympathetic Autonomic System Injury and Small Fiber Neuropathy.

    Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.

    Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.

  8. Autonomous System Assessement.

    Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.

    Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.

  9. Evolution of the use of analgesic treatments.

    Time frame: From baseline to day 60.

    Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.

  10. Analgesic Response Analysis

    Time frame: From baseline to day 60.

    Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients

  11. Improvement of pain triggered by a stimulus (allodynia).

    Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.

    Comparison between the 3 groups of allodynia improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan HODAJ, MD

CONTACT

[email protected]

04-76-76-52-13 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Randomized Double-blind Study of RTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term RTMS-induced Brain Changes Using FMRI.

Acronym: NEUROSTIM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2021
Registry last updated
Dec 6, 2024

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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