StrokePhase 2NCT03337867
Theta-Burst-Stimulation in Recurrent Stroke Recovery
A Phase 2 study testing Magstim Super Rapid2 System in people with Stroke and Neurorehabilitation, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Stroke, Neurorehabilitation
- What is being tested?
- Magstim Super Rapid2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2018to 1 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written consent
- age: 40-90 years
- recurrent stroke
- hemiparesis with impaired hand motor function
Who cannot join
- Subjects who are legally detained in an official institute (§20 MPG)
- Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- Medication pump (e.g. insulin pump)
- Metal splinters in eye or head
- Pregnancy / breastfeeding
- Severe Neurodegenerative disease
Show all 13Show fewer
- Severe Neuroinflammatory disease
- History of seizures / epilepsy
- Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
- Insufficient compliance
- Present or past malignant tumor involving the central nervous system
- Severe Psychiatric disease
- Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
Read the detailed description
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
- Conditions
- Stroke, Neurorehabilitation
- Being tested
- Magstim Super Rapid2 System
- Keywords
- Recurrent stroke, Stroke, Transcranial Magnetic Stimulation, Theta-Burst-Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Super Rapid2 SystemDevice
Intermittent theta-burst-stimulation (iTBS) protocol
Magstim Super Rapid2 SystemDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real-iTBS | Active comparator | Not described Receives: Device: Magstim Super Rapid2 System |
| Sham-iTBS | Sham comparator | Not described Receives: Device: Magstim Super Rapid2 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative grip force
grip force as measured with vigorimeter
Measured: 3 months after enrollment
Secondary outcomes (12)
Relative grip force
Grip force as measured with vigorimeter
Measured: After 8 days of intervention, and 3 months of enrollment
Motor function
Action Research Arm Test, ARAT
Measured: After 8 days of intervention, and 3 months of enrollment
Motor function
Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.
Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed
Measured: After 8 days of intervention, and 3 months of enrollment
Stroke severity
National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: After 8 days of intervention, and 3 months of enrollment
Degree of disability
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
Measured: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Motor evoked potential
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
Measured: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Resting motor threshold
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
Measured: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Short-interval intracortical inhibition
Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
Measured: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Ipsilateral silent period
Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition. Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
Measured: After 8 days of intervention, and 3 months of enrollment
Quality of life
EuroQol 5D questionnaire, EQ-5D
Measured: After 8 days of intervention, and 3 months of enrollment
Activities of daily living at admission and discharge in external rehabilitation facility
Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The scale yield a score of 0-100.
Measured: After 8 days of intervention, and 3 months of enrollment
Days of rehabilitation after intervention phase
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start11 Jan 2018
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Grefkes, University Hospital of Cologne
- Investigators
- Christian Grefkes, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337867
- Sponsor's protocol ID
- U1111-1204-6783
- Status last verified
- Nov 2019
- First submitted
- 3 Nov 2017
- Last updated
- 27 Nov 2019
- 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 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta-Burst-Stimulation in Recurrent Stroke Recovery
- ClinicalTrials.gov ID
- NCT03337867
- Acronym / sponsor ID
- U1111-1204-6783
- Conditions
- Stroke, Neurorehabilitation
- Keywords
- Recurrent stroke, Stroke, Transcranial Magnetic Stimulation, Theta-Burst-Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 9 Nov 2017 (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.
The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
Detailed description
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-iTBS | Active comparator | Device: Magstim Super Rapid2 System |
| Sham-iTBS | Sham comparator | Device: Magstim Super Rapid2 System |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written consent
- age: 40-90 years
- recurrent stroke
- hemiparesis with impaired hand motor function
Key exclusion criteria (13 listed)
- Subjects who are legally detained in an official institute (§20 MPG)
- Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- Medication pump (e.g. insulin pump)
- Metal splinters in eye or head
- Pregnancy / breastfeeding
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 |
|---|---|---|
| Magstim Super Rapid2 SystemIntermittent theta-burst-stimulation (iTBS) protocol | Device | Real-iTBS |
| Magstim Super Rapid2 SystemSham stimulation | Device | Sham-iTBS |
Primary outcome
Relative grip force
Time frame: 3 months after enrollment
grip force as measured with vigorimeter
12 secondary outcomes
Relative grip force
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor function
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor function
Time frame: After 8 days of intervention, and 3 months of enrollment
Stroke severity
Time frame: After 8 days of intervention, and 3 months of enrollment
Degree of disability
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Motor evoked potential
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Resting motor threshold
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Short-interval intracortical inhibition
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Ipsilateral silent period
Time frame: After 8 days of intervention, and 3 months of enrollment
Quality of life
Time frame: After 8 days of intervention, and 3 months of enrollment
Activities of daily living at admission and discharge in external rehabilitation facility
Time frame: After 8 days of intervention, and 3 months of enrollment
Days of rehabilitation after intervention phase
Time frame: 3 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
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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. This study is not recruiting at the moment.
Christian Grefkes, MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magstim Super Rapid2 System in people with Stroke and Neurorehabilitation, run by University Hospital of Cologne at 1 site in Germany.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative grip force (time frame: 3 months after enrollment). 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 Nov 2019.