Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
NCT ID: NCT04936646
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2021-07-16
2025-12-01
Brief Summary
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* Classical rTMS stimulation
* Deeper rTMS stimulation
* Sham rTMS stimulation
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Classic rTMS Stimulation using the B65 Coil
RepetitiveTranscranial Magnetic Stimulation (rTMS)
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.
Deeper rTMS Stimulation using the B70 Coil
RepetitiveTranscranial Magnetic Stimulation (rTMS)
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.
control group with a sham stimulation using a sham coil
RepetitiveTranscranial Magnetic Stimulation (rTMS)
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.
Interventions
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RepetitiveTranscranial Magnetic Stimulation (rTMS)
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Hasan HODAJ, MD
Role: PRINCIPAL_INVESTIGATOR
CHUGA
Locations
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Centre de la douleur, CHU Grenoble Alpes
Grenoble, Isère, France
Countries
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Central Contacts
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Facility Contacts
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HODAj Hasan, MD
Role: primary
Other Identifiers
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38RC20192
Identifier Type: -
Identifier Source: org_study_id