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

Sponsor
University Hospital, Clermont-Ferrand
Study ID
NCT07202455
Status
Not Yet Recruiting

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Conditions

  • Central Post Stroke Pain
  • Neuropathic Pain
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Oct 1, 2025
Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Active group
    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.
  • Sham Comparator: Control group
    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.

Primary Outcome Measure

Development of neuropathic pain [ Time Frame: At 6 months post-stroke ]

Central Contacts

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