Informations générales (source: ClinicalTrials.gov)
Non-invasive Analgesic Stimulation of the Motor Cortex at Home (STIMATHOME)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
février 2015
mai 2027
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD) - 69500 - Bron - France | Luis Garcia-Larrea, Doctor | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria :
- 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.
Exclusion Criteria :
- 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.
(No limitation in the inclusion of male patients old enough to procreate).
- Patient under legal protective measure.
- Pregnant women and nursing mothers
- 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.
Exclusion Criteria :
- 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.
(No limitation in the inclusion of male patients old enough to procreate).
- Patient under legal protective measure.
- Pregnant women and nursing mothers