StrokeInterActNCT06381388
Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke
A study testing cTBS in people with Stroke, run by Jord Vink at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- cTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Oct 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥ 18 years;
- Signed informed consent.
- Normal motor function with a minimum Motricity Index (MI) of 99.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
De Hoogstraat Revalidatie
Utrecht, Utrecht
Anne Visser-Meily, MD, PhD, +31 88 75 588 31, j.m.a.visser-meily@umcutrecht.nl
About this study
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.
Read more
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
- Being tested
- cTBS
- Keywords
- Stroke, Transcranial magnetic stimulation, Continuous theta burst stimulation, Upper limb recovery, TMS, cTBS, Interhemispheric inhibition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cTBSDevice
A single cTBS session delivered to the contralesional primary motor cortex.
| Study group | Role | What they receive |
|---|---|---|
| Active cTBS | Experimental | cTBS delivered with an active TMS coil Receives: Device: cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 minutes after cTBS
Secondary outcomes (4)
Ipsilesional resting motor threshold (RMT)
Ipsilesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.
Measured: Within 30 minutes after cTBS
Contralesional resting motor threshold (RMT)
Contralesional RMT in percentage of machine output. Outcome ranges from 0 to 100%.
Measured: Within 30 minutes after cTBS
TMS interference
Finger tapping frequency change in response to TMS interference of the contralesional M1.
Measured: Within 30 minutes after cTBS
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.
Measured: Within 30 minutes after cTBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start11 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jord Vink
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jord Vink, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381388
- Sponsor's protocol ID
- NL86587.041.24
- Acronym
- InterAct
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT06381388
- Acronym / sponsor ID
- InterAct / NL86587.041.24
- Conditions
- Stroke
- Keywords
- Stroke, Transcranial magnetic stimulation, Continuous theta burst stimulation, Upper limb recovery, TMS, cTBS, Interhemispheric inhibition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jord VinkUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active cTBS | Experimental | Device: cTBScTBS delivered with an active TMS coil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cTBSA single cTBS session delivered to the contralesional primary motor cortex. | Device | Active cTBS |
Primary outcome
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.
4 secondary outcomes
Ipsilesional resting motor threshold (RMT)
Time frame: Within 30 minutes after cTBS
Contralesional resting motor threshold (RMT)
Time frame: Within 30 minutes after cTBS
TMS interference
Time frame: Within 30 minutes after cTBS
Intracortical inhibition (ICI)
Time frame: Within 30 minutes after cTBS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cTBS in people with Stroke, run by Jord Vink at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jord Vink, PhD (+31634959811, j.j.vink-5@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interhemispheric inhibition (IHI) (time frame: Within 30 minutes after cTBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.