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NCT Number: NCT06381388

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cTBS

Device

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

Primary outcomes

  1. Interhemispheric inhibition (IHI)

    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.

Secondary outcomes

  1. Ipsilesional resting motor threshold (RMT)

    Time frame: Within 30 minutes after cTBS

    Ipsilesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.

  2. Contralesional resting motor threshold (RMT)

    Time frame: Within 30 minutes after cTBS

    Contralesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.

  3. TMS interference

    Time frame: Within 30 minutes after cTBS

    Finger tapping frequency change in response to TMS interference of the contralesional M1.

  4. Intracortical inhibition (ICI)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jord Vink, PhD

CONTACT

[email protected]

+31634959811

Sponsors and collaborators

Lead sponsor

Jord Vink

Other

Registry information

Acronym: InterAct

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 24, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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