Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04936646

Randomized Double-blind Study Comparing Three Types of Repetitive Transcranial Magnetic Stimulation for Chronic Neuropathic Pain and Brain Changes Using FMRI

Led by University Hospital, Grenoble · Updated on 2024-12-06

45

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pain relief effects of three different types of repetitive Transcranial Magnetic Stimulation (rTMS) for people with chronic neuropathic pain that has lasted more than a year and has not responded to usual treatments. The study compares classical rTMS, deeper rTMS, and a placebo (sham) stimulation to understand which method may better reduce pain. The trial is randomized and double-blinded to ensure fair comparison among the groups. Participants undergo neurostimulation sessions following a set schedule: one session daily for five days during the first week, then three sessions in the second week, one session in the third week, and two monthly sessions thereafter. The treatment period lasts seven weeks, after which patients are monitored for an additional two weeks. The study uses different coils for stimulation including the B65 coil for classical rTMS, the B70 coil for deeper stimulation, and a sham coil for placebo treatment. During the study, participants record their daily pain levels using a Visual Numeric Scale (VNS) starting one week before treatment begins and continuing throughout the treatment and follow-up periods. Researchers assess pain progression from the start to the end of treatment and examine brain changes using imaging at day 60. Other measures include response rates, quality of life, anxiety and depression symptoms, and changes in use of pain medications. The total study duration for each participant spans approximately nine weeks, including baseline, treatment, and follow-up assessments.

CONDITIONS

Brief Title

Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient's written consent
  • Affiliated with social security system
  • Male or female with unilateral refractory neuropathic pain lasting more than one year
  • Stable analgesic treatment for at least one month
  • Not responding to conventional treatments
  • Prescreening EVN >3
Not Eligible

You will not qualify if you...

  • History of drug addiction, epilepsy, or cranial trauma
  • History of psychiatric disorder
  • Previous treatment with repetitive Transcranial Magnetic Stimulation (rTMS)
  • Presence of intracranial ferromagnetic material or implanted stimulator
  • New pain treatment started less than one month ago
  • Pregnant or breastfeeding women
  • Patients who do not understand the study protocol
  • Persons legally protected under the law

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline

Duration - 1 week

Participants record their daily pain intensity on a diary form for 1 week before treatment begins.

Daily diary entries

Treatment

Duration - 7 weeks

Participants receive neurostimulation sessions over seven weeks with varying session frequency across the weeks.

Sessions daily for 5 days in week 1, 3 sessions in week 2, 1 session in week 3, and 2 monthly sessions thereafter

Follow-up

Duration - 2 weeks

Participants are followed for 2 weeks after the end of neurostimulation sessions while continuing to record daily pain intensity.

Daily diary entries

Trial Site Locations

Total: 1 location

1

Centre de la douleur, CHU Grenoble Alpes

Grenoble, Isère, France, 38043

Actively Recruiting

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Research Team

H

Hasan HODAJ, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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