StrokeENADANCT07202455
Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
A study testing Active tDCS in people with Stroke and Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Neuropathic Pain, Central Post Stroke Pain
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU Clemront-Ferrand
Clermont-Ferrand
Lise Laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Xavier Moisset
CH Etienne Clémentel
Enval, 63530
Lise Laclautre, +33 4 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
About this study
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.
Read the detailed description
Selection: during hospitalization in the neurology department of Clermont-Ferrand University Hospital, the principal investigator will propose that eligible patients take part in the ENADA study. If the patient agrees, an inclusion visit (E1) will be scheduled by the inclusion center. All these patients will have had an MRI recording as part of routine post-stroke practice.
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 a maximum of 21 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.
- Conditions
- Stroke, Neuropathic Pain, Central Post Stroke Pain
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- neuropathic pain, prevention, stroke, central post stroke pain, neuromodulation, tDCS
- Medical subject headings
- Stroke, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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 tDCSDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 months post-stroke
Secondary outcomes (14)
Development of non-neuropathic pain
shoulder or other joint pain, spasticity-related pain, etc.
Measured: At 6 months post-stroke
Pain intensity
Numeric Rating Scale (NRS) ranging from 0 (no pain) to 100 (worst pain imaginable)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: After the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Brain activity
resting-state fMRI
Measured: Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fleming plan (40 patients in the active group, 20 in the control group)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Moisset, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202455
- Sponsor's protocol ID
- RBHP 2025 MOISSET 2
- Other IDs
- 2025-A00988-41
- Acronym
- ENADA
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
- ClinicalTrials.gov ID
- NCT07202455
- Acronym / sponsor ID
- ENADA / RBHP 2025 MOISSET 2
- Conditions
- Stroke, Neuropathic Pain, Central Post Stroke Pain
- Keywords
- neuropathic pain, prevention, stroke, central post stroke pain, neuromodulation, tDCS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Selection: during hospitalization in the neurology department of Clermont-Ferrand University Hospital, the principal investigator will propose that eligible patients take part in the ENADA study. If the patient agrees, an inclusion visit (E1) will be scheduled by the inclusion center. All these patients will have had an MRI recording as part of routine post-stroke practice.
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 a maximum of 21 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Fleming plan (40 patients in the active group, 20 in the control group)
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: Active tDCSPatients will receive 10 sessions of active tDCS stimulation (2mA, 20 minutes, 0.1mA/s ramp-up and ramp-down), in addition to conventional rehabilitation. |
| Control group | Sham comparator | Device: Sham tDCSPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSPatients 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. | Device | Active group |
| Sham tDCSPatients 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. | Device | Control group |
Primary outcome
Development of neuropathic pain
Time frame: 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).
14 secondary outcomes
Development of non-neuropathic pain
Time frame: At 6 months post-stroke
Pain intensity
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-stroke
Affective pain experience
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-stroke
Presence of neuropathic pain
Time frame: 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
Time frame: Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Pain assessment
Time frame: Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Motor function
Time frame: Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Spasticity
Time frame: Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Anxiety and depression
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the protocol and at six months post-stroke
Bang Blinding Index
Time frame: After the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Brain activity
Time frame: Before and after the protocol (within 7 days after the 10th and final tDCS session) and at six months post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier Moisset principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Stroke and Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of neuropathic pain (time frame: At 6 months post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.