Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: cTBS

• Registration Number: NCT06381388
• Lead Sponsor: Jord Vink

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-17
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Study Start: 2024-06-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active cTBS	cTBS	cTBS delivered with an active TMS coil

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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%.

Trial Locations

Locations (1)

De Hoogstraat Revalidatie; 🇳🇱 Utrecht, Netherlands