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

NCT07202455 | Not Yet Recruiting

• 2 other identifiers: RBHP 2025 MOISSET 22025-A00988-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Stroke; Neuropathic Pain; Central Post Stroke Pain

Keywords

neuropathic pain; prevention; stroke; central post stroke pain; neuromodulation; tDCS

Outcome Measures

Primary Outcomes (1)

• Development of neuropathic pain

  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).

  At 6 months post-stroke

Secondary Outcomes (14)

• Development of non-neuropathic pain

  At 6 months post-stroke

• Pain intensity

  Before the protocol, within 15 minutes before and after each tDCS session, after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke

• Affective pain experience

  Before the protocol, within 15 minutes before and after each tDCS session, after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke

• Presence of neuropathic pain

  Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke

• Evaluation of neuropathic pain

  Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke

Study Arms (2)

Active group

ACTIVE COMPARATOR

Patients will receive 10 sessions of active tDCS stimulation (2mA, 20 minutes, 0.1mA/s ramp-up and ramp-down), in addition to conventional rehabilitation.

Device: Active tDCS

Control group

SHAM COMPARATOR

Patients will receive 10 sessions of sham tDCS stimulation (2mA, 20 minutes, 0.1mA/s ramp-up, stimulation stopped after the current ramp), in addition to conventional rehabilitation.

Device: Sham tDCS

Interventions

Active tDCS DEVICE

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.

Active group

Sham tDCS DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU Clemront-Ferrand

Clermont-Ferrand, France

Location

CH Etienne Clémentel

Enval, 63530, France

Location

MeSH Terms

Conditions

Stroke; Neuralgia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier Moisset

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fleming plan (40 patients in the active group, 20 in the control group)

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)