Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain

NCT07202455 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Clermont-Ferrand

Phase

Not applicable

Started

2026-01-01

Last updated

2025-12-23

Condition(s) studied

StrokeNeuropathic PainCentral Post Stroke Pain

Investigational drug(s) / intervention(s)

Active tDCSSham tDCS

Active tDCS: Patients will receive 10 sessions of tDCS stimulation (2mA, 20 minutes with a current on/off ramp of 0.1 mA/s) delivered with a Sooma DUO stimulator. Sooma DUO is a transcranial direct current stimulation (tDCS) device. The device generates a current that modulates brain activity. This current is delivered via electrodes attached to the patient's head.

Sham tDCS: Patients will receive 10 sessions of sham tDCS stimulation (2mA, 20 minutes, 0.1mA/s ramp-up, stimulation stopped after the current ramp), delivered with a Sooma DUO stimulator. Sooma DUO is a transcranial direct current stimulation (tDCS) device. The device generates a current that modulates brain activity. This current is delivered via electrodes attached to the patient's head.

Study 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 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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)

Primary outcome measure(s)

Development of neuropathic pain — At 6 months post-stroke
The primary endpoint is the development (yes/no) of probable or definite neuropathic pain according to IASP criteria, after clinical and instrumental assessment, at 6 months post-stroke. The presence of definite neuropathic pain will be recorded in the presence of negative sensory signs, i.e. partial or complete loss of one or more sensory modalities (e.g. light touch, cold temperature, etc.) concordant with the lesion of the somatosensory nervous system (in this case stroke, the presence of which will have been confirmed by MRI).

Trial sites (2)

Facility	City	Region	Status
CHU Clemront-Ferrand	Clermont-Ferrand	France
CH Etienne Clémentel	Enval	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07202455 on ClinicalTrials.gov ↗ ← All trials in France