Stroke
Conditions
Keywords
Stroke, Transcranial magnetic stimulation, Continuous theta burst stimulation, Upper limb recovery, TMS, cTBS, Interhemispheric inhibition
Brief summary
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.
Interventions
DEVICEcTBS
A single cTBS session delivered to the contralesional primary motor cortex.
Sponsors
Jord Vink
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for patients: * 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. Inclusion Criteria for healthy controls: * Age ≥ 18 years; * Signed informed consent. * Normal motor function with a minimum Motricity Index (MI) of 99.
Exclusion criteria
* Disabling medical conditions (severe heart disease, severe head trauma, severe mental illness); * Severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician; * 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); * Life expectancy shorter than one year; * Upper limb paresis prior to stroke onset.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interhemispheric inhibition (IHI) | Within 30 minutes after cTBS | Contralesional to ipsilesional IHI measured with a condition pulse delivered over the contralesional M1 and a test pulse delivered over the ipsilesional M1 with an interstimulus interval of 10ms. An aggregated measure (unitless) is obtained by dividing the conditioned motor-evoked potential (MEP) amplitude (in Volts) by the unconditioned MEP amplitude (in Volts). A value smaller than 1 indicates inhibition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilesional resting motor threshold (RMT) | Within 30 minutes after cTBS | Ipsilesional RMT in percentage of machine output. Outcome ranges from 0 to 100%. |
| Contralesional resting motor threshold (RMT) | Within 30 minutes after cTBS | Contralesional RMT in percentage of machine output. Outcome ranges from 0 to 100%. |
| TMS interference | Within 30 minutes after cTBS | Finger tapping frequency change in response to TMS interference of the contralesional M1. |
| Intracortical inhibition (ICI) | Within 30 minutes after cTBS | Intracortical inhibition in the contralesional M1 with an interstimulus interval of 2ms. An aggregated measure (unitless) is obtained by dividing the conditioned motor-evoked potential (MEP) amplitude (in Volts) by the unconditioned MEP amplitude (in Volts). A value smaller than 1 indicates inhibition. |
Countries
Netherlands
Contacts
Primary ContactJord Vink, PhD
Outcome results
None listed