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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active tDCS
DevicePatients 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
DevicePatients 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active groupActive comparator 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
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).
Time frame
At 6 months post-strokeSecondary outcomes
1
Development of non-neuropathic pain
shoulder or other joint pain, spasticity-related pain, etc.
Time frame
At 6 months post-stroke2
Pain intensity
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 100 (worst pain imaginable)
Time frame
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-stroke3
Affective pain experience
Numeric Rating Scale (NRS) ranging from 0 (no affective impact of pain) to 100 (worst affective impact of pain)
Time frame
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-stroke4
Presence of neuropathic pain
Douleur Neuropathique en 4 questions (DN4)
Time frame
Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-strokeSponsors and contacts
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Source ClinicalTrials.gov
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