Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02910024
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gereon R. Fink, University of Cologne

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol Device: Magstim Super Rapid2 System, sham-stimulation (in iTBS) Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten
Study Start Date : April 2016
Estimated Primary Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. Relative grip force [ Time Frame: 3 months after enrollment ]
    grip force as measured with vigorimeter


Secondary Outcome Measures :
  1. Relative grip force [ Time Frame: after 8 days of intervention, and 3 months after enrollment ]
    grip force as measured with vigorimeter

  2. Motor function [ Time Frame: after 8 days of intervention, and 3 months after enrollment ]
    Action Research Arm Test, ARAT

  3. Motor function [ Time Frame: after 8 days of intervention, and 3 months after enrollment ]
    Fugl-Meyer Motor Scale of the upper extremity, FM

  4. Stroke severity [ Time Frame: after 8 days of intervention, and 3 months after enrollment ]
    National Instituts of Health Stroke Scale, NIHSS

  5. Degree of disability [ Time Frame: after 8 days of intervention, and 3 months after enrollment ]
    modified Rankin Scale, mRS

  6. 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

  7. 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

  8. Quality of life [ Time Frame: after 8 days of intervention, and 3 months after enrollment ]
    EuroQol 5D questionnaire, EQ-5D

  9. 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

  10. Days of rehabilitation after intervention phase [ Time Frame: 3 months after enrollment ]
    Days of rehabilitation after intervention phase as documented by external rehabilitation facility



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910024


Contacts
Layout table for location contacts
Contact: Gereon R Fink, Univ.-Prof. Dr. +49 221 478 4455 gereon.fink@uk-koeln.de
Contact: Christian B Grefkes, Univ.-Prof. Dr. +49 221 478 87695 christian.grefkes@uk-koeln.de

Locations
Layout table for location information
Germany
Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln Recruiting
Cologne, North Rhine-Westphalia, Germany, 50924
Contact: Lukas Hensel, Dr.    +49 221 478 82873    lukas.hensel@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
Layout table for investigator information
Principal Investigator: Gereon R Fink, Univ.-Prof. Dr. University of Cologne

Layout table for additonal information
Responsible Party: Gereon R. Fink, Prof. Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT02910024     History of Changes
Other Study ID Numbers: Uni-Koeln-1778
U1111-1172-6026 ( Other Identifier: WHO )
CIV-15-09-013868 ( Other Identifier: EUDAMED )
DRKS00008963 ( Registry Identifier: DRKS )
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases