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2026-526884-39-00Not yet recruitingPhase 3

Effect of GABAergic treatments on cortical plasticity and motor learning capacity in the subacute phase after stroke: a single-case experimental study (GABAPLAST)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Sept 2026

Next steps

Brief summary (registry, in English)

Compare the capacity for cerebral plasticity evaluated in electrophysiology before and after the introduction of gabaergic treatment in subacute post-stroke patients with anxiety (Oxazepam), spasticity (Baclofen) or neuropathic pain (Gabapentin).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
12 (estimated)
First submitted
3 Jun 2026
Start date
1 Oct 2026
Lead sponsor
Centre Hospitalier Universitaire De Toulouse
Diseases
Stroke
EU CT number
2026-526884-39-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 12
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults 2 weeks to 6 months after a stroke who need a new GABA-acting medicine (Oxazepam, Baclofen or Gabapentin) for anxiety, spasticity or nerve pain.

Age
18 years and over
Sex
All
Disease stage
Ischaemic or haemorrhagic stroke in the subacute phase, 2 weeks to 6 months after the stroke. A symptom score (PGI-S) of 2 or more. No movement problem in the non-paretic hand.
Earlier treatment
Must not have had Oxazepam, Gabapentin or Baclofen for more than 7 days recently. Must not have had a benzodiazepine, Z-drug, morphine, pregabalin, sedative antipsychotic or barbiturate for more than 7 days recently.
Biomarker or test result
An MRI done in routine care at the time of the stroke diagnosis. Enough language understanding (BDAE score above 3).

Main reasons for not taking part

  • Needs the medicine immediately, for example severe anxiety, severe spasticity or severe nerve pain
  • Medical reasons against brain stimulation (TMS safety questionnaire)
  • Other brain or nerve disease besides stroke, such as epilepsy, multiple sclerosis or brain tumour
  • Severe mental illness such as schizophrenia or bipolar disorder, or dependence on a psychoactive substance
  • Pregnancy or breast-feeding

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or recent treatment ( > 7 days) with a gabaergic drug of interest (oxazepam, gabapentin, baclofen)
  • Need to introduce the planned drug immediately: - Oxazepam: severe anxiety or panic attack requiring immediate treatment; severe depressive episode; current suicidal ideation or identified suicide risk; psychological distress considered by the investigator to be incompatible with an observation period of up to 15 days; - Baclofen: severe, painful or rapidly progressive spasticity requiring immediate introduction of systemic drug therapy; - Gabapentin: severe or insufficiently controlled neuropathic pain requiring immediate drug therapy.

Lab values

  • Contraindication to the planned medicine: - Oxazepam: severe respiratory failure, untreated sleep apnoea syndrome, acute or chronic severe hepatic impairment, myasthenia gravis, hypersensitivity to oxazepam or any of the excipients, galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome; - Baclofen: hypersensitivity to baclofen or any of the excipients, wheat allergy or celiac disease; - Gabapentin: hypersensitivity to gabapentin or any other excipient, galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
    • Presence of a major peripheral neuromuscular disorder (e.g. severe motor neuropathy) making the interpretation of PEM unreliable.
    • Guardianship, curatorship, safeguarding of justice
    • Current or recent treatment ( > 7 days) with any prohibited treatment (benzodiazepine, Z-drug, morphine, pregabalin, sedative antipsychotic or barbiturate).
    • History of neurological disorders other than stroke, for example: neurodegenerative disease, multiple sclerosis, epilepsy, brain tumour, hydrocephalus.
    • History of severe psychiatric conditions, such as schizophrenia or bipolar disorder
    • pregnancy or breast-feeding
    • Presence of dependence on a psychoactive substance
    • Skin disorder in the stimulated hand indicating the placement of electromyographic collection or stimulation electrodes

Other

  • Medical contraindications for the performance of MSDs according to the TMS safety questionnaire in Appendix 3

Who the study is looking for

  • Adults aged 18 and over
  • Confirmed diagnosis of ischaemic or haemorrhagic stroke, subacute (defined as 2 weeks to 6 months after stroke).
  • Presence of a non-urgent indication at the introduction of a gabaergic treatment, for which the delay of introduction provided for in the protocol is considered medically acceptable by the investigator.
  • The PGI-S of the symptom associated with the indication is greater than or equal to 2.
  • Sufficient understanding to participate in the study: BDAE > 3 score.
  • Performing an MRI during routine care at the time of stroke diagnosis (allowing neuronavigation)
  • Absence of motor impairment on the non-paretic hand
  • affiliation with a national health insurance system
  • Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any review required by the research).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire de ToulouseToulouseFranceNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.