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

NCT06381388 | Recruiting

• 1 other identifier: NL86587.041.24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Transcranial magnetic stimulation; Continuous theta burst stimulation; Upper limb recovery; TMS; cTBS; Interhemispheric inhibition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ipsilesional resting motor threshold (RMT)

  Within 30 minutes after cTBS

• Contralesional resting motor threshold (RMT)

  Within 30 minutes after cTBS

• TMS interference

  Within 30 minutes after cTBS

• Intracortical inhibition (ICI)

  Within 30 minutes after cTBS

Study Arms (1)

Active cTBS

EXPERIMENTAL

cTBS delivered with an active TMS coil

Device: cTBS

Interventions

cTBS DEVICE

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

Active cTBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent.
• Age ≥ 18 years;
• Signed informed consent.
• Normal motor function with a minimum Motricity Index (MI) of 99.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jord Vink: lead

Study Sites (1)

De Hoogstraat Revalidatie

Utrecht, Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jord Vink, PhD

CONTACT

+31634959811; j.j.vink-5@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 24, 2024
• Study Start: October 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)