Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
This is a prospective clinical study to evaluate the efficacy of tDCS stimulation, coupled with conventional rehabilitation, on the development of post-stroke neuropathic pain.
The study involves a double-blind, randomized, sham-controlled experimental protocol involving 2 parallel groups with patients allocated according to a Fleming design (40 patients in the active group, 20 patients in the control group).
The study is aimed at sub-acute post-stroke patients. After recruitment, they will receive 10 sessions of tDCS stimulation (2mA, 20 minutes with a current on/off ramp of 0.1 mA/s). For the control group, stimulation will stop after the current ramp.
Eligibility criteria
Qualifiers
Age ≥18 years
Ischemic or hemorrhagic stroke confirmed by MRI or scanner
Lesion(s) in somato-sensory areas (i.e. mainly in: the pons, thalamus, internal capsule, basal ganglia and operculo-insular regions)
Sensory and/or motor deficit requiring rehabilitation
Disqualifiers
Contraindication to tDCS (epilepsy/history of epilepsy, intracranial ferromagnetic material or implanted stimulator, acute eczema or irritated skin over the stimulation area)
Contraindication to MRI (use of a pacemaker or insulin pump, wearing of a metal prosthesis, intracerebral clip or piercing, claustrophobia)
Cognitive or language difficulties preventing comprehension of instructions and/or correct clinical assessment
Patients participating in another research protocol involving a drug in the 30 days prior to inclusion
Trial design
Treatments tested in this trial
- Active tDCS
- Sham tDCS
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov