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

Trial details

Who runs it

Centre Hospitalier Universitaire De Toulouse

Trial code

EU 2026-526884-39-00

Record updated

2026. szeptember 1.

Original description

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).Read full original descriptionShow less

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).

Inclusion: 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).

Exclusion: 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; 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; Medical contraindications for the performance of MSDs according to the TMS safety questionnaire in Appendix 3.

EU CTIS 2026-526884-39-00