Neuropathic PainSTIMATHOMENCT02346396
Cortical Stimulation by Direct Current for the Treatment of Chronic Pain : Pilot-study of a Stimulation Device at Home
A study testing tDCS (use at home) in people with Neuropathic Pain, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- tDCS (use at home)
- 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
- 9 Feb 2015to 9 May 2027
- 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
- Patients from 18 to 80 years old, men or women, suffering pharmaco-resistant neuropathic chronic pain for more than one year; NVS > 2 during the week S0) unilateral pharmacoresistant, whose analgesic treatment is stable for at least 1 month.
- Patients whose pharmacoresistance leads their referent doctor to consider non-pharmacological therapeutic alternatives and begin a presurgical assessment.
- Patients having an operational Internet connection. The patient or one person of its circle of acquaintances will have to be able to connect on the Internet and to reach by this way the system of relocated stimulation ("The Cloud").
- Patients having shown pain relief to a single- or whole-week sessions of tDCS are not excluded from potential recruitment for this study.
- Patients having a social security cover.
- Patients having given their written consent.
Who cannot join
- History
- of addiction to drugs,
- of epilepsy.
- Présence of an intra-cranial ferromagnetic equipment or of an implanted stimulation device (e.g. stimulating, central grey pacemaker, stimulation of the basal ganglia or of the vagus nerve).
- Introduction of a new analgesic treatment for less than a month.
- Lack of a effective contraception for all the duration of the study for the patients old enough to procreate.
Show all 9Show fewer
- (No limitation in the inclusion of male patients old enough to procreate).
- Patient under legal protective measure.
- Pregnant women and nursing mothers
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
Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)
Bron, 69500
Luis Garcia-Larrea, Doctor, 4 72 35 78 88 ext. +33, larrea@univ-lyon1.fr
Nathalie André-Obadia, Doctor, 4 72 35 70 68 ext. +33, nathalie.obadia-andre@chu-lyon.fr
About this study
Official title: Non-invasive Analgesic Stimulation of the Motor Cortex at Home
The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home.
It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014).
No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.
- Conditions
- Neuropathic Pain
- Being tested
- tDCS (use at home)
- Keywords
- neuropathic pain, neurostimulation, ambulatory use, tDCS
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS (use at home)Device
During 4 weeks (every week : 20 minutes / day during 5 days)
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuropathic chronic pain | Experimental | Not described Receives: Device: tDCS (use at home) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).
Measured: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)
Measured: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study start9 Feb 2015
- Primary completion9 May 2027 (estimated)
- Study completion9 May 2027 (estimated)
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
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
- NCT02346396
- Sponsor's protocol ID
- 2014.869
- Other IDs
- 2014-A01437-40
- Acronym
- STIMATHOME
- Status last verified
- Dec 2023
- First submitted
- 7 Jan 2015
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Analgesic Stimulation of the Motor Cortex at Home
- ClinicalTrials.gov ID
- NCT02346396
- Acronym / sponsor ID
- STIMATHOME / 2014.869
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain, neurostimulation, ambulatory use, tDCS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Feb 2015 (actual)
- Primary completion
- 9 May 2027 (estimated)
- Study completion
- 9 May 2027 (estimated)
- First posted
- 27 Jan 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 purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home.
It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014).
No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neuropathic chronic pain | Experimental | Device: tDCS (use at home) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients from 18 to 80 years old, men or women, suffering pharmaco-resistant neuropathic chronic pain for more than one year; NVS > 2 during the week S0) unilateral pharmacoresistant, whose analgesic treatment is stable for at least 1 month.
- Patients whose pharmacoresistance leads their referent doctor to consider non-pharmacological therapeutic alternatives and begin a presurgical assessment.
- Patients having an operational Internet connection. The patient or one person of its circle of acquaintances will have to be able to connect on the Internet and to reach by this way the system of relocated stimulation ("The Cloud").
- Patients having shown pain relief to a single- or whole-week sessions of tDCS are not excluded from potential recruitment for this study.
- Patients having a social security cover.
Key exclusion criteria (9 listed)
- History
- of addiction to drugs,
- of epilepsy.
- Présence of an intra-cranial ferromagnetic equipment or of an implanted stimulation device (e.g. stimulating, central grey pacemaker, stimulation of the basal ganglia or of the vagus nerve).
- Introduction of a new analgesic treatment for less than a 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 |
|---|---|---|
| tDCS (use at home)During 4 weeks (every week : 20 minutes / day during 5 days) | Device | Patients with neuropathic chronic pain |
Primary outcome
Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).
Time frame: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)
Time frame: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
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 2 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS (use at home) in people with 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 6 inclusion and 9 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 2 Jan 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. 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 Luis Garcia-Larrea, Doctor (4 72 35 78 88 ext. +33, larrea@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep). (time frame: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)). 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 2 Jan 2024.