Theta-Burst-Stimulation in Early Rehabilitation of Stroke (TheSiReS)

September 19, 2022 updated by: Gereon R. Fink, University of Cologne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50924
        • Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written consent
  • age: 40-90 years
  • ischemic stroke
  • hemiparesis with impaired hand motor function

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real-rTMS
Repetitive 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
Device: Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol
iTBS applied over ipsilesional M1
Sham Comparator: Sham-rTMS
Repetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days
Device: Magstim Super Rapid2 System, sham-stimulation (in iTBS)
iTBS applied with tilted coil over parieto-occipital vertex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative grip force
Time Frame: 3 months after enrollment
grip force as measured with vigorimeter
3 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of rehabilitation after intervention phase
Time Frame: 3 months after enrollment
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
3 months after enrollment
Relative grip force
Time Frame: after 8 days of intervention, and 3 months after enrollment
grip force as measured with vigorimeter
after 8 days of intervention, and 3 months after enrollment
Motor function
Time Frame: after 8 days of intervention, and 3 months after enrollment
Action Research Arm Test, ARAT
after 8 days of intervention, and 3 months after enrollment
Motor function
Time Frame: after 8 days of intervention, and 3 months after enrollment
Fugl-Meyer Motor Scale of the upper extremity, FM
after 8 days of intervention, and 3 months after enrollment
Stroke severity
Time Frame: after 8 days of intervention, and 3 months after enrollment
National Instituts of Health Stroke Scale, NIHSS
after 8 days of intervention, and 3 months after enrollment
Degree of disability
Time Frame: after 8 days of intervention, and 3 months after enrollment
modified Rankin Scale, mRS
after 8 days of intervention, and 3 months after enrollment
Motorcortex excitability
Time Frame: after 8 days of intervention, and 3 months after enrollment
Motor evoked potential induced by stimulation of the affected motor cortex, MEP
after 8 days of intervention, and 3 months after enrollment
Motorcortex excitability
Time Frame: after 8 days of intervention, and 3 months after enrollment
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
after 8 days of intervention, and 3 months after enrollment
Quality of life
Time Frame: after 8 days of intervention, and 3 months after enrollment
EuroQol 5D questionnaire, EQ-5D
after 8 days of intervention, and 3 months after enrollment
Activities of daily living at admission and discharge in external rehabilitation facility
Time Frame: 3 months after enrollment
Barthel-Index (BI) scores as documented by external rehabilitation facility
3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Gereon R Fink, Univ.-Prof. Dr., University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-1778
  • U1111-1172-6026 (Other Identifier: WHO)
  • CIV-15-09-013868 (Other Identifier: EUDAMED)
  • DRKS00008963 (Registry Identifier: DRKS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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