NCT06381388Recruiting
Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke
Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear. Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls. Study design: A prospective, open-label within-subject intervention study Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls. Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Mar 2024
- Start date
- 11 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Jord Vink
- Diseases
- Stroke
- NCT number
- NCT06381388
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 11 Oct 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to TMS and/or MRI (ferrous implants, history of epilepsy, drug or alcohol abuse over a period of 6 months prior to the experiment, pregnancy);
- Upper limb paresis prior to stroke onset.
Other illness
- Disabling medical conditions (severe heart disease, severe head trauma, severe mental illness);
Other
- Severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician;
- Life expectancy shorter than one year;
Who the study is looking for
- Age ≥ 18 years;
- First-ever ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;
- Unilateral paresis of an upper extremity with a Motricity Index (MI) between 9 and 99
- Inclusion possible between 3 weeks and 6 weeks after stroke onset;
- Signed informed consent.
- Age ≥ 18 years;
- Signed informed consent.
- Normal motor function with a minimum Motricity Index (MI) of 99.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| De Hoogstraat Revalidatie Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.