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De klinische studie NCT07202455 (ENADA) voor Beroerte, Neuropathische pijn, Central Post Stroke Pain is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain (ENADA)
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.
Inclusion (E1 visit): A new background check and inclusion/non-inclusion criteria will be carried out. Once the patient has signed the study consent form, he or she will complete the self-questionnaires (VAS pain intensity, VAS pain affectivity, DN4, NPSI, BPI, HAD, diagram showing hypoesthetic areas, EQ-5D). The evaluation will also include FMA-UE test, the modified Ashworth scale and sensory thresholds.
Randomization: Patients will be randomized to the active or placebo group.
Protocol: 10 stimulation sessions, spread over 10 consecutive working days. Active and sham tDCS sessions are identical, double-blind. Stimulation by tDCS takes place during a physiotherapy, occupational therapy or speech therapy session. After installation, stimulation lasts 20 minutes. Stimulation is delivered at an intensity of 2 mA, with a ramp for the onset and disappearance of the current. Sham stimulation stops after the onset ramp, ensuring blindness for the patient, who may feel a slight tingling sensation during this phase. Patients will complete a pain intensity VAS and an affective pain VAS before and after each tDCS stimulation.
Post-protocol visit (visit E2): this visit is scheduled 7 days after the 10th and last stimulation session. It is carried out by the principal investigator at Clermont-Ferrand University Hospital.
An MRI recording is scheduled for this visit. Patients will fill in follow-up self-questionnaires (pain intensity VAS, affective pain VAS, DN4, NPSI, BPI, HAD, diagram showing hypoesthetic areas, EQ-5D), as well as their overall impression of change (PGIC score) and their impression of change on motor and sensory aspects. The evaluation will also include FMA-UE test and the modified Ashworth scale. The quality of blinding will be assessed at visit E2 by asking the patient's impression of the treatment he or she has received and of the presumed allocation (Bang blinding index).
End-of-study visit (E3 visit): this visit is scheduled at 6 months post-stroke. It is conducted by the principal investigator at the Clermont-Ferrand University Hospital.
The same assessments are carried out as at the previous visit, as well as the evaluation of sensory thresholds. In addition, the presence of neuropathic pain (yes/no), the primary endpoint, was assessed after clinical and instrumental evaluation. The presence of non-neuropathic pain (yes/no) is also assessed.
Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
- ENADA
- RBHP 2025 MOISSET 2
- 2025-A00988-41 (Overige identificatiecode) (2025-A00988-41)
prevention
stroke
central post stroke pain
neuromodulation
tDCS
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorActive 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. | Actieve 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. |
SchijncomparatorControl 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. | Nep-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. |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Development of non-neuropathic pain | shoulder or other joint pain, spasticity-related pain, etc. | At 6 months post-stroke |
Pain intensity | Numeric Rating Scale (NRS) ranging from 0 (no pain) to 100 (worst pain imaginable) | 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 | Numeric Rating Scale (NRS) ranging from 0 (no affective impact of pain) to 100 (worst affective impact of pain) | 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 | Douleur Neuropathique en 4 questions (DN4) | 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 | Questionnaire d'évaluation des douleurs neuropathiques (NPSI) | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Pain assessment | Questionnaire concis sur les douleurs (BPI) | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Motor function | Fugl-Meyer Assessment - Upper extremity (FMA-UE) test, ranging from 0 (worst motor function) to 66 (correct motor function) | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Spasticity | Modified Ashworth Scale (MAS), ranging from 0 (no increase in muscle tone) to 4 (affectied part rigid in flexion or extension) | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Anxiety and depression | Hospital Anxiety and Depression (HAD) scale, ranging from 0 (no symptoms) to 21 (most severe symptoms) | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Quality of life EQ-5D | EQ-5D scale, each item coded from 1 (no problem) to 3 (extreme problem) | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Patient's impression of change | Patient's global impression of change, impression of change in motor and sensory aspects, ranging from 1 (very significantly improved) to 7 (very significantly worsened) | After the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Perceptual and pain hot and cold thresholds | Thermal thresholds evaluated with a Thermotest, in the area with the most pronounced sensory symptoms and the contralateral similar area | Before the protocol and at six months post-stroke |
Bang Blinding Index | Patient's impression of being in the active or control group, each patient report his/her impression (active group/control group/don't know) and proportions are compared between the active and control group | After the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
Brain activity | resting-state fMRI | Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke |
- Age ≥18 years
- Ischemic or hemorrhagic stroke confirmed by MRI
- 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
- 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
University Hospital, Clermont-Ferrand