Chronic Neuropathic PainNEUROSTIMNCT04936646
Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,
A study testing RepetitiveTranscranial Magnetic Stimulation (rTMS) in people with Chronic Neuropathic Pain, run by University Hospital, Grenoble at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Neuropathic Pain
- What is being tested?
- RepetitiveTranscranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de la douleur, CHU Grenoble Alpes
Grenoble, Isère, 38043
HODAj Hasan, MD
About this study
Official 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.
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
Read the detailed description
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.
- Conditions
- Chronic Neuropathic Pain
- Being tested
- RepetitiveTranscranial Magnetic Stimulation (rTMS)
- Keywords
- rTMS, Chronic neuropathic pain, Repetitive Transcranial Magnetic Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Classic rTMS Stimulation using the B65 Coil | Experimental | Not described Receives: Device: RepetitiveTranscranial Magnetic Stimulation (rTMS) |
| Deeper rTMS Stimulation using the B70 Coil | Experimental | Not described Receives: Device: RepetitiveTranscranial Magnetic Stimulation (rTMS) |
| control group with a sham stimulation using a sham coil | Sham comparator | Not described Receives: Device: RepetitiveTranscranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).
Measured: Day 60 from the beginning of rTMS treatment compared to baseline.
Rate of Responding Patients.
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.
Measured: week 7 compared with baseline
Assessment of Overall Patient Improvement.
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).
Measured: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Quality of Life Improvement.
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.
Measured: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Evolution of Anxiety and Depressive Traits.
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.
Measured: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Evolution of Symptomatological Profiles of Neuropathic Pain.
Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Measured: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Measured: Day 60 from the beginning of rTMS treatment compared to baseline.
Autonomous System Assessement.
Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Measured: Day 60 from the beginning of rTMS treatment compared to baseline.
Evolution of the use of analgesic treatments.
Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Measured: From baseline to day 60.
Analgesic Response Analysis
Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients
Measured: From baseline to day 60.
Improvement of pain triggered by a stimulus (allodynia).
Comparison between the 3 groups of allodynia improvement.
Measured: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start16 Jul 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasan HODAJ, MD, Principal investigator, CHUGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936646
- Sponsor's protocol ID
- 38RC20192
- Acronym
- NEUROSTIM
- Status last verified
- Dec 2024
- First submitted
- 3 Jun 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04936646
- Acronym / sponsor ID
- NEUROSTIM / 38RC20192
- Conditions
- Chronic Neuropathic Pain
- Keywords
- rTMS, Chronic neuropathic pain, Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Classic rTMS Stimulation using the B65 Coil, Deeper rTMS Stimulation using the B70 Coil, control group with a sham stimulation using a sham coil |
Primary outcome
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).
11 secondary outcomes
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.
Rate of Responding Patients.
Time frame: week 7 compared with baseline
Assessment of Overall Patient Improvement.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Quality of Life Improvement.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Evolution of Anxiety and Depressive Traits.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Evolution of Symptomatological Profiles of Neuropathic Pain.
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.
Autonomous System Assessement.
Time frame: Day 60 from the beginning of rTMS treatment compared to baseline.
Evolution of the use of analgesic treatments.
Time frame: From baseline to day 60.
Analgesic Response Analysis
Time frame: From baseline to day 60.
Improvement of pain triggered by a stimulus (allodynia).
Time frame: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hasan HODAJ, MD principal investigator
CHUGA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RepetitiveTranscranial Magnetic Stimulation (rTMS) in people with Chronic Neuropathic Pain, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan HODAJ, MD (04-76-76-52-13 ext. 33, HHodaj@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Pain. (time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.