Pharmacoresistant Neuropathic PainNI-MCSNCT01800136
Analgesic Effect of Non Invasive Stimulation : Comparison of rTMS and tDCS Efficacy
A study testing Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation in people with Pharmacoresistant Neuropathic Pain, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pharmacoresistant Neuropathic Pain
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2013to 17 Jun 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged from 18 to 80 years, male or female, fully informed and having given their written consent
- pharmacoresistant neuropathic pain during at least one year, without any change of the pharmacological treatment since at least one month
Who cannot join
- drug addiction, headache, epilepsy history
- ferromagnetic intracranial device
- implanted stimulator
- absence of contraceptive method for women of childbearing age
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL
Lyon, 69000
About this study
Official title: Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS
The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.
- Conditions
- Pharmacoresistant Neuropathic Pain
- Being tested
- Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation
- Keywords
- pain, neuropathic, cortical stimulation, motor cortex, plasticity, rTMS, tDCS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current StimulationDevice
Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| rTMS; tDCS | Experimental | Not described Receives: Device: Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week
Measured: Here the Time Frames : Baseline; 1 week; 2 week; 3 week
Secondary outcomes (4)
objective evaluation of sleep quality
actimetry measures
Measured: Change from Baseline in percentage of sleep time at the end of the stimulation week; at the end of the first post-stimulation week; and at the end of the of the second post-stimulation week
subjective evaluation of sleep quality using a numerical auto-evaluation scale
the patient is asked to evaluate each day the quality of his sleep using a numerical scale from 0 to 10.
Measured: Change from Baseline in level of tiredness at the end of the stimulation week;at the end of the first post-stimulation week; and at the end of the second post-stimulation week
nociceptive and non-nociceptive thresholds
Electrical stimulation of variable intensities applied on the hand
Measured: Change from Baseline in nociceptive threshold after the first day of stimulation;after the fifth day of stimulation;Change from Baseline in non-nociceptive threshold after the first day of stimulation;and after the fifth day of stimulation
evaluation of motor cortex plasticity
displacement of activation locus found after voluntary movements; comparison of the plastic and analgesic effects of rTMS or tDCS
Measured: Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study start13 Jan 2013
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacoresistant Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800136
- Sponsor's protocol ID
- 2011.662
- Other IDs
- 2008-A01379-32
- Acronym
- NI-MCS
- Status last verified
- Aug 2019
- First submitted
- 30 Oct 2012
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS
- ClinicalTrials.gov ID
- NCT01800136
- Acronym / sponsor ID
- NI-MCS / 2011.662
- Conditions
- Pharmacoresistant Neuropathic Pain
- Keywords
- pain, neuropathic, cortical stimulation, motor cortex, plasticity, rTMS, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Jan 2013 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 27 Feb 2013 (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 aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS; tDCS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged from 18 to 80 years, male or female, fully informed and having given their written consent
- pharmacoresistant neuropathic pain during at least one year, without any change of the pharmacological treatment since at least one month
Key exclusion criteria (4 listed)
- drug addiction, headache, epilepsy history
- ferromagnetic intracranial device
- implanted stimulator
- absence of contraceptive method for women of childbearing age
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current StimulationFive sessions of HF-rTMS or tDCS applied daily during 5 consecutive days | Device | rTMS; tDCS |
Primary outcome
Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week
Time frame: Here the Time Frames : Baseline; 1 week; 2 week; 3 week
4 secondary outcomes
objective evaluation of sleep quality
Time frame: Change from Baseline in percentage of sleep time at the end of the stimulation week; at the end of the first post-stimulation week; and at the end of the of the second post-stimulation week
subjective evaluation of sleep quality using a numerical auto-evaluation scale
Time frame: Change from Baseline in level of tiredness at the end of the stimulation week;at the end of the first post-stimulation week; and at the end of the second post-stimulation week
nociceptive and non-nociceptive thresholds
Time frame: Change from Baseline in nociceptive threshold after the first day of stimulation;after the fifth day of stimulation;Change from Baseline in non-nociceptive threshold after the first day of stimulation;and after the fifth day of stimulation
evaluation of motor cortex plasticity
Time frame: Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week
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 3 Sep 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation in people with Pharmacoresistant Neuropathic Pain, run by Hospices Civils de Lyon 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 2 inclusion and 4 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 3 Sep 2019. 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?
Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week (time frame: Here the Time Frames : Baseline; 1 week; 2 week; 3 week). 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 3 Sep 2019.