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

Stroke Clinical Trial

— InterAct  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381388
• Other study ID #: NL86587.041.24
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2024
• Source: UMC Utrecht
• Contact: Jord Vink, PhD
• Phone: +31634959811
• Email: j.j.vink-5[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• cTBS
A single cTBS session delivered to the contralesional primary motor cortex.

Locations

Country	Name	City	State
Netherlands	De Hoogstraat Revalidatie	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Jord Vink

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interhemispheric inhibition (IHI)	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.	Within 30 minutes after cTBS
Secondary	Ipsilesional resting motor threshold (RMT)	Ipsilesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.	Within 30 minutes after cTBS
Secondary	Contralesional resting motor threshold (RMT)	Contralesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.	Within 30 minutes after cTBS
Secondary	TMS interference	Finger tapping frequency change in response to TMS interference of the contralesional M1.	Within 30 minutes after cTBS
Secondary	Intracortical inhibition (ICI)	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.	Within 30 minutes after cTBS