NCT04936646

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

4.2 years

First QC Date

June 3, 2021

Last Update Submit

December 3, 2024

Conditions

Chronic Neuropathic Pain

Keywords

rTMSChronic neuropathic painRepetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Evolution of Pain.

    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).

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

Secondary Outcomes (11)

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

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

  • Rate of Responding Patients.

    week 7 compared with baseline

  • Assessment of Overall Patient Improvement.

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

  • Quality of Life Improvement.

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

  • Evolution of Anxiety and Depressive Traits.

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

  • +6 more secondary outcomes

Study Arms (3)

Classic rTMS Stimulation using the B65 Coil

EXPERIMENTAL
Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)

Deeper rTMS Stimulation using the B70 Coil

EXPERIMENTAL
Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)

control group with a sham stimulation using a sham coil

SHAM COMPARATOR
Device: RepetitiveTranscranial Magnetic Stimulation (rTMS)

Interventions

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.

Classic rTMS Stimulation using the B65 CoilDeeper rTMS Stimulation using the B70 Coilcontrol group with a sham stimulation using a sham coil

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de la douleur, CHU Grenoble Alpes

Grenoble, Isère, 38043, France

RECRUITING

Study Officials

  • Hasan HODAJ, MD

    CHUGA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan HODAJ, MD

CONTACT

04-76-76-52-13HHodaj@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 23, 2021

Study Start

July 16, 2021

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)