Status:
NOT_YET_RECRUITING
Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Stroke
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 d...
Detailed Description
Selection: during hospitalization in the neurology department of Clermont-Ferrand University Hospital, the principal investigator will propose that eligible patients take part in the ENADA study. If t...
Eligibility Criteria
Inclusion
- 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
- Subacute stage (7 to 45 days post-stroke)
- No neurological deficit or chronic neuropathic pain prior to stroke
- No neuropathic pain at inclusion
- Patient can be followed throughout the study.
- Information letter read and understood
- Able to give informed consent to participate in research
- Affiliation with a social security scheme
Exclusion
- 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
- Drug or psychoactive substance abuse
- Pregnant or breast-feeding women
- Patients under guardianship or curatorship, deprived of liberty, safeguard of justice
- Major depression
- Patients with Parkinson's disease
- The presence of pre-existing lesions \>1.5 cm (maximum diameter) in a cerebral area belonging to the anatomically defined sensorimotor system
- Alcohol abuse
- Severe psychiatric disorders (e.g., schizophrenia)
- Any tumor disease with a life expectancy of \<1 year
- Increased intracranial pressure
- Patients with a medical device containing electronics or conductive materials
- Patients on continuous oxygen (system not adapted)
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07202455
Start Date
January 1 2026
End Date
April 30 2029
Last Update
December 23 2025
Active Locations (2)
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1
CHU Clemront-Ferrand
Clermont-Ferrand, France
2
CH Etienne Clémentel
Enval, France, 63530