Neuropathic PainNCT02386969
Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain
A study of Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2015to 12 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Central neuropathic pain
- Chronic pain with an average pain intensity is greater than or equal to 40/100
- Pain presents a daily or almost daily (at least 4 days out of 7)
- Pain presents for more than 6 months
- Patients who signed informed consent,
- Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
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- Patients can be monitored for the duration of the study (29 weeks)
- Patients affiliated to a health insurance plan or entitled,
- Patients with a cerebral MRI T1.
Who cannot join
- Labor dispute or Accident,
- Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
- Abuse of drugs or psychoactive substances
- Peripheral Neuropathic Pain,
- Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
- Intermittent pain,
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- Pain in less than 6 months,
- Presence of other pain more severe than that justify inclusion,
- Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
- Patients unable to understand informed consent, under guardianship,
- Patients refusing to stop or can not stop the prohibited treatment during the study,
- Patients participating in another research protocol involving a drug within 30 days before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.
Read the detailed description
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.
- Conditions
- Neuropathic Pain
- Being tested
- active rTMS then sham rTMS, sham rTMS then active rTMS
- Keywords
- Neuropathic Pain, repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS then sham rTMSDevice
A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months
sham rTMS then active rTMSDevice
A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS then sham rTMS | Experimental | Active rTMS in 1st period and sham rTMS in 2nd period Receives: Device: active rTMS then sham rTMS |
| Sham rTMS then active rTMS | Experimental | Sham rTMS in 1st period and active rTMS in 2nd period Receives: Device: sham rTMS then active rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
Measured: 3 weeks later the last session of rTMS (active ) so week n°12
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
Measured: 3 weeks later the last session of rTMS (sham) so week n°29.
Secondary outcomes (6)
Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").
Measured: 3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.
Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Measured: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Measured: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Neuropathic dimension
specific paper questionnaire of neuropathic pain NPSI at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)
Measured: at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)
- Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.
Measured: at the end of each period of 4 sessions (weeks n°12 and 29)
Consumption of analgesic treatment
Measured: 3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start11 Nov 2015
- Primary completion29 Mar 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386969
- Sponsor's protocol ID
- 1408207
- Other IDs
- 2015-A00065-44
- Status last verified
- Apr 2021
- First submitted
- 5 Mar 2015
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02386969
- Acronym / sponsor ID
- 1408207
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, repetitive transcranial magnetic stimulation (rTMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 12 Mar 2015 (estimated)
- 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 repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.
Detailed description
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS then sham rTMS | Experimental | Device: active rTMS then sham rTMSActive rTMS in 1st period and sham rTMS in 2nd period |
| Sham rTMS then active rTMS | Experimental | Device: sham rTMS then active rTMSSham rTMS in 1st period and active rTMS in 2nd period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Central neuropathic pain
- Chronic pain with an average pain intensity is greater than or equal to 40/100
- Pain presents a daily or almost daily (at least 4 days out of 7)
- Pain presents for more than 6 months
- Patients who signed informed consent,
Key exclusion criteria (12 listed)
- Labor dispute or Accident,
- Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
- Abuse of drugs or psychoactive substances
- Peripheral Neuropathic Pain,
- Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
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 |
|---|---|---|
| active rTMS then sham rTMSA first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months | Device | Active rTMS then sham rTMS |
| sham rTMS then active rTMSA first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months | Device | Sham rTMS then active rTMS |
Primary outcome
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")
Time frame: 3 weeks later the last session of rTMS (active ) so week n°12
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain
Time frame: 3 weeks later the last session of rTMS (sham) so week n°29.
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
6 secondary outcomes
Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").
Time frame: 3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.
Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Time frame: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Time frame: before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)
Neuropathic dimension
Time frame: at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)
- Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.
Time frame: at the end of each period of 4 sessions (weeks n°12 and 29)
Consumption of analgesic treatment
Time frame: 3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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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. This study is not recruiting at the moment.
Roland PEYRON, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neuropathic Pain, run by Centre Hospitalier Universitaire de Saint Etienne 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 26 Apr 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ") (time frame: 3 weeks later the last session of rTMS (active ) so week n°12). The study lists 2 primary outcomes in all. 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 26 Apr 2021.