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StrokePhase 2/3TheSiReSNCT02910024

Theta-Burst-Stimulation in Early Rehabilitation of Stroke

A Phase 2/3 study testing Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol in people with Stroke, run by University of Cologne at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Stroke
What is being tested?
Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteGermany
Study dates
Apr 2016to 15 Sep 2022
Phase
Phase 2/3
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
  • ischemic stroke
  • hemiparesis with impaired hand motor function

Who cannot join

  • Subjects who are legally detained in an official institute (§20 MPG)
  • Participation in clinical trial within the last 12 weeks
  • 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
Show all 24Show fewer
  • Severe Neurodegenerative disease
  • 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
  • Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis
  • Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae <1cm)
  • Known brain lesion (surgical, traumatic)
  • Evidence for enhanced cerebral pressure
  • Severe cardial dysfunction
  • life expectancy < 12 months
  • NIHSS Score > 20
  • Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)
  • Elevated blood pressure resistant to treatment (RR > 185/110mmHg)
  • Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study
  • 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.

Germany1 site

  • Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50924

Other trials in Germany

About this study

Official title: Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten

The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke. Patients with hemipresis will receive either sham or real iTBS over their affected hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after the intervention phase and three months after enrollment.

Read the detailed description

To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients.

Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria.

Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.

Conditions
Stroke
Being tested
Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol, Magstim Super Rapid2 System, sham-stimulation (in iTBS)
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 System, intermittent theta-burst-stimulation (iTBS) protocolDevice

    iTBS applied over ipsilesional M1

  • Magstim Super Rapid2 System, sham-stimulation (in iTBS)Device

    iTBS applied with tilted coil over parieto-occipital vertex

Study groups in NCT02910024
Study groupRoleWhat they receive
Real-rTMSActive comparatorRepetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in the lesioned hemisphere using the intermittent theta-burst-stimulation protocol (iTBS; application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 seconds, repeated every 10 seconds, duration of one session: about 3,5 minutes) before physiotherapy for 8 days
Receives: Device: Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol
Sham-rTMSSham comparatorRepetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days
Receives: Device: Magstim Super Rapid2 System, sham-stimulation (in iTBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative grip force

    grip force as measured with vigorimeter

    Measured: 3 months after enrollment

Secondary outcomes (10)

  1. Relative grip force

    grip force as measured with vigorimeter

    Measured: after 8 days of intervention, and 3 months after enrollment

  2. Motor function

    Action Research Arm Test, ARAT

    Measured: after 8 days of intervention, and 3 months after enrollment

  3. Motor function

    Fugl-Meyer Motor Scale of the upper extremity, FM

    Measured: after 8 days of intervention, and 3 months after enrollment

  4. Stroke severity

    National Instituts of Health Stroke Scale, NIHSS

    Measured: after 8 days of intervention, and 3 months after enrollment

  5. Degree of disability

    modified Rankin Scale, mRS

    Measured: after 8 days of intervention, and 3 months after enrollment

  6. Motorcortex excitability

    Motor evoked potential induced by stimulation of the affected motor cortex, MEP

    Measured: after 8 days of intervention, and 3 months after enrollment

  7. Motorcortex excitability

    Resting motor threshold as measured by stimulation of the affected motor cortex, RMT

    Measured: after 8 days of intervention, and 3 months after enrollment

  8. Quality of life

    EuroQol 5D questionnaire, EQ-5D

    Measured: after 8 days of intervention, and 3 months after enrollment

  9. Activities of daily living at admission and discharge in external rehabilitation facility

    Barthel-Index (BI) scores as documented by external rehabilitation facility

    Measured: 3 months after enrollment

  10. 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.

  1. First posted21 Sep 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion15 Sep 2022
  4. Study completion15 Sep 2022

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02910024
Sponsor's protocol ID
Uni-Koeln-1778
Other IDs
U1111-1172-6026, CIV-15-09-013868, DRKS00008963
Acronym
TheSiReS
Status last verified
Sep 2022
First submitted
8 Sep 2016
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hensel L, Grefkes C, Tscherpel C, Ringmaier C, Kraus D, Hamacher S, Volz LJ, Fink GR. Intermittent theta burst stimulation applied during early rehabilitation after stroke: study protocol for a randomised controlled trial. BMJ Open. 2019 Dec 30;9(12):e034088. doi: 10.1136/bmjopen-2019-034088.

    PubMed 31892668

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol in people with Stroke, run by University 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 24 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: finished, as of the sponsor's last update on 21 Sep 2022. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

On the ClinicalTrials.gov record for NCT02910024, which also lists 1 linked publication.

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 21 Sep 2022.

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