2026-526884-39-00招募中3 期
Effect of GABAergic treatments on cortical plasticity and motor learning capacity in the subacute phase after stroke: a single-case experimental study (GABAPLAST)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Variation (Δ) in the amplitude of the motor evoked potential (MEP) induced by a Paired Associative Stimulation (PAS) protocol, expressed as the percentage change between pre-PAS and post-PAS measurements, assessed at each session
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •Current or recent treatment ( > 7 days) with a gabaergic drug of interest (oxazepam, gabapentin, baclofen)
- •Medical contraindications for the performance of MSDs according to the TMS safety questionnaire in Appendix 3
- •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
结局指标
主要结局
Variation (Δ) in the amplitude of the motor evoked potential (MEP) induced by a Paired Associative Stimulation (PAS) protocol, expressed as the percentage change between pre-PAS and post-PAS measurements, assessed at each session
Variation (Δ) in the amplitude of the motor evoked potential (MEP) induced by a Paired Associative Stimulation (PAS) protocol, expressed as the percentage change between pre-PAS and post-PAS measurements, assessed at each session
次要结局
- Cortical excitability (TMS): resting motor threshold, MEP amplitude and latency, assessed at each session.
- Motor learning performance: learning effect, rebound, and retention on SRTT and Target Jump tasks, assessed at each session.
- Safety: spontaneous report on adverse events, assessed at each session
- Severity of the symptom that led to treatment prescription reported by the patient using the Patient Global Impression of Severity (PGI-S)
研究者
Emmeline Montané
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (1)
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