De Hoogstraat Revalidatie
Utrecht, Netherlands
Location status: Recruiting
NCT Number: NCT06381388
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Utrecht, Netherlands
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients:
Inclusion criteria
for healthy controls:
Exclusion criteria
A single cTBS session delivered to the contralesional primary motor cortex.
Time frame: 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.
Time frame: Within 30 minutes after cTBS
Ipsilesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.
Time frame: Within 30 minutes after cTBS
Contralesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.
Time frame: Within 30 minutes after cTBS
Finger tapping frequency change in response to TMS interference of the contralesional M1.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Jord Vink
Other
Acronym: InterAct
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