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Effect of baclofen, gabapentin and oxazepam on brain plasticity and motor learning in subacute stroke patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial investigates the effect of three medicines that influence the GABA system on people who have experienced a recent Stroke. The medicines tested are baclofen, which is used to reduce muscle stiffness, gabapentin, which is used for nerve‑related pain, and oxazepam, which is used for anxiety. The study is identified by the code name GABAPLAST.

The purpose of the study is to compare how these medicines change the brain’s ability to reorganize (known as cortical plasticity) and the capacity to learn new motor tasks during the early recovery period after a stroke. Cortical plasticity refers to the brain’s natural ability to form new connections and adapt after injury, and motor learning describes how well a person can acquire and retain new movement skills.

Participants will undergo a series of short visits in which brain activity is measured, a simple learning task is performed, and the assigned medication is taken for a set period. Measurements are taken before the medication starts and after each treatment phase, allowing researchers to see any changes over time while safety is continuously checked.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study, you will sign a consent form that explains the purpose of the research and what will be required of you.

    The study staff will confirm that you meet the eligibility criteria for a subacute post‑stroke participant.

  2. Step 2

    Baseline assessments

    Before any medication is started, a series of measurements will be taken to evaluate brain and motor function.

    These include a motor evoked potential (MEP) test using paired associative stimulation, other cortical excitability tests, and two motor‑learning tasks called the serial reaction time task and the target jump task.

    You will also complete a safety questionnaire and rate the severity of the symptom that led to the prescribed treatment using a simple global impression scale.

  3. Step 3

    Start of study medication

    Once the baseline assessments are finished, you will begin taking the medication assigned for your condition:

    baclofen: 90 mg total per day, taken orally as tablets.

    gabapentin: 1800 mg total per day, taken orally as capsules.

    oxazepam: 60 mg total per day, taken orally as tablets.

    The exact schedule for taking the tablets or capsules will follow the study protocol.

  4. Step 4

    Regular follow‑up sessions

    During the treatment period, you will attend repeated study sessions.

    At each session the same set of measurements performed at baseline will be repeated: the MEP test, cortical excitability assessments, the motor‑learning tasks, the safety questionnaire, and the symptom‑severity rating.

    These repeated assessments allow the researchers to compare brain and motor function before and after the medication.

  5. Step 5

    Final evaluation and study completion

    At the end of the treatment period, a final set of assessments identical to the earlier sessions will be performed.

    After the final evaluation, the study medication will be discontinued and the study will be concluded for you.

Who can join the trial?

9 criteria

  • Be an adult who is 18 years old or older.
  • Have a confirmed diagnosis of ischemic (caused by a blocked blood vessel) or hemorrhagic (caused by bleeding) stroke that is in the subacute stage, meaning it occurred between 2 weeks and 6 months ago.
  • Need to start a gabaergic medication (a drug that works on the brain’s GABA system) for a reason that is not urgent, and the doctor believes waiting as described in the study is safe.
  • Score at least 2 on the PGI‑S (Patient Global Impression of Severity) for the symptom that will be treated.
  • Be able to understand the study, shown by a BDAE (Boston Diagnostic Aphasia Examination) score greater than 3.
  • Have had an MRI (magnetic resonance imaging) scan done as part of regular care when the stroke was diagnosed, allowing doctors to use neuronavigation.
  • Have no motor weakness in the hand that was not affected by the stroke.
  • Be covered by a national health insurance system.
  • Provide free, informed, written consent that is signed by you and the investigator before any study procedures begin.

Who cannot join the trial?

14 criteria

  • You have taken, or stopped taking within the last 7 days, any of the study drugs (oxazepam, baclofen, or gabapentin) that affect the brain chemical GABA.
  • You have medical reasons that make the use of the brain‑stimulation test (called TMS) unsafe, according to the safety questionnaire.
  • You need the study drug right away because of very severe anxiety, panic attacks, a serious depressive episode, thoughts of suicide, extreme psychological distress, painful or rapidly worsening muscle stiffness (spasticity), or uncontrolled nerve pain. In such cases you cannot wait for the study schedule.
  • You have a health condition that makes the planned medication unsafe, such as:
    • For oxazepam: severe breathing problems, untreated sleep apnea, serious liver disease, muscle weakness disease called myasthenia gravis, allergy to the drug, or inability to digest certain sugars (galactose intolerance, lactase deficiency, glucose‑galactose malabsorption).
    • For baclofen: allergy to the drug or its ingredients, wheat allergy, or celiac disease.
    • For gabapentin: allergy to the drug or its ingredients, or the same sugar‑digestion problems listed above.
    • You have a major peripheral neuromuscular disorder (for example, severe damage to the nerves that control muscles) that would make the test results unreliable.
    • You are under legal guardianship or similar protection that would prevent you from giving independent consent for the study.
    • You have taken, or stopped taking within the last 7 days, any prohibited medicines such as benzodiazepines, “Z‑drugs” (sleep aids), morphine, pregabalin, sedating antipsychotics, or barbiturates.
    • You have a history of other brain or nervous system diseases besides stroke, such as dementia, multiple sclerosis, epilepsy (seizure disorder), brain tumor, or fluid buildup in the brain (hydrocephalus).
    • You have a history of severe mental health conditions like schizophrenia or bipolar disorder.
    • You are currently pregnant or are breastfeeding.
    • You have a dependence on psychoactive substances (drugs that affect the mind, such as certain illegal drugs or misuse of prescription medications).
    • You have a skin problem on the hand where the study would place small electrodes for muscle activity recording (electromyography), making it unsafe to attach the equipment.
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Investigated drugs

  • Baclofen

    is a muscle‑relaxing medicine that is often used to reduce spasticity, which is tightness or stiffness in the muscles after a stroke. In this study, participants who have muscle stiffness take baclofen so researchers can see whether easing the spasticity helps the brain become more adaptable and improves the ability to learn new motor skills.

  • Gabapentin

    is a drug commonly prescribed for nerve‑related (neuropathic) pain. The trial gives gabapentin to stroke survivors who experience this type of pain to find out if relieving the pain also supports changes in the brain that are needed for learning and recovering movement.

  • Oxazepam

    is a short‑acting medication that helps reduce anxiety. Some participants in the study have anxiety after their stroke, and they receive oxazepam so researchers can examine whether calming anxiety influences the brain’s capacity to reorganize and improve motor learning.

What is already known about the treatment

  • baclofen

    Baclofen is taken as an oral tablet that can be split for flexible dosing. It is an approved medicine widely used to treat muscle spasticity after conditions such as stroke. It works by activating GABA‑B receptors in the spinal cord, which reduces nerve signal transmission and relaxes muscles. It belongs to the class of muscle relaxants and GABA‑B receptor agonists.

  • gabapentin

    Gabapentin is taken as a hard gelatin capsule, available in strengths such as 100 mg, 300 mg, and 400 mg. It is an approved drug used for neuropathic pain and for certain seizure disorders. It binds to the α2δ subunit of voltage‑gated calcium channels, decreasing the release of excitatory neurotransmitters and calming nerve activity. It is classified as an anticonvulsant and analgesic and is a structural analog of GABA.

  • oxazepam

    Oxazepam is taken as an oral tablet. It is an approved benzodiazepine used for short‑term relief of anxiety and related symptoms. It enhances the activity of GABA‑A receptors, increasing the inhibitory effect of GABA in the brain. It belongs to the class of benzodiazepine anxiolytics.

Investigated diseases

Stroke - Stroke is a sudden loss of blood supply to a part of the brain, usually caused by a blocked artery or a burst blood vessel. The lack of oxygen and nutrients quickly damages brain cells in the affected area, leading to an abrupt loss of function such as weakness, speech problems, or vision changes. Within hours to days, swelling can increase pressure and extend the injury to nearby tissue. Over the following weeks, the brain may begin to reorganize, allowing some recovery as remaining cells adapt and form new connections. In some individuals, the initial damage can expand if edema or other secondary changes develop.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526884-39-00Protocol codeRC31/25/0619Estimated enrolment12 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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