Understanding Neuromodulation of the Stroke Brain

Understanding Neuromodulation of the Stroke Brain - UNOS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48250

Enrollment

Registered

2019-01-24

Start date

2020-01-14

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebrovascular accident Stroke

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adult patient age >= 18; 2. First-ever ischemic stroke in one hemisphere; 3. Unilateral paresis of an upper extremity with at least a palpable voluntarily muscle contraction of the deltoid muscle and a maximum Motricity Index (MI) of the hand of 25 (i.e. less force in the affected hand during performance of an opposing thumb movement task compared to the unaffected hand); 4. Inclusion possible between 3 weeks and 3 months after stroke onset; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Other disabling medical conditions (severe heart disease, severe head trauma, severe mental illness); 2. Severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician; 3. Contraindications for TMS and MRI (ferrous objects in or around the body, history of epilepsy, drug or alcohol abuse over a period of 6 months prior to the experiment, pregnancy).

Design outcomes

Primary

Measure	Time frame
The primary outcome measures will be the changes in RMT, IHI, iSP and ICI in response to contralesional cTBS. The primary outcome measures are described below:	—

Secondary

Measure	Time frame
1. The second secondary outcome parameter is the difference in change in RMT, IHI, iSP and ICI in response to contralesional cTBS treatment between the subacute phase and the chronic phase after stroke. 2. The first secondary outcome parameter is the difference in RMT, IHI, iSP and ICI between the population of stroke patients and healthy age-matched controls at two different time points. 3. The relationship of the aforementioned electrophysiological parameters with sensorimotor function test scores (ARAT/FM), white matter integrity (based on MRI), functional network organization (based on fMRI).	—

Measure

Time frame

1. The second secondary outcome parameter is the difference in change in RMT, IHI, iSP and ICI in response to contralesional cTBS treatment between the subacute phase and the chronic phase after stroke. 2. The first secondary outcome parameter is the difference in RMT, IHI, iSP and ICI between the population of stroke patients and healthy age-matched controls at two different time points. 3. The relationship of the aforementioned electrophysiological parameters with sensorimotor function test scores (ARAT/FM), white matter integrity (based on MRI), functional network organization (based on fMRI).

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Countries

Netherlands

Outcome results