Trial document




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  DRKS00008963

Trial Description

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Title

Theta-Burst-Stimulation in early Rehabilitation of Stroke

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Trial Acronym

TheSiReS

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URL of the Trial

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Brief Summary in Lay Language

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 means of a technical intervention: During so called "repetitive transcranial magnetic stimulation" (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS), magnetic pulses are repeatedly applied through the skull into the motor cortex of the brain. This leads to an increase of brain activity and excitability of the motor cortex, in order to enhance motor training effects during subsequent physiotherapy. 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 (stimulation not affecting the motor cortex). In the first weeks and after three months, grip force, mobility, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00008963
  •   2016/02/16
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  •   yes
  •   Approved
  •   15-343, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1172-6026 
  •   CIV-15-09-013868 
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Health Condition or Problem studied

  •   Stroke with hemiparesis including impaired hand motor function
  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   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
  •   Sham-stimulation before physiotherapy for 8 days
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

grip force after 3 months (measured with vigorimeter)

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Secondary Outcome

After 8 days of intervention, and three months after stroke:

Grip force (vigorimeter);
Motor function (Action Research Arm Test, ARAT; Fugl-Meyer Motor Scale of the upper extremity, FM);
Stroke severity (National Instituts of Health Stroke Scale, NIHSS);
Degree of disability (modified Rankin Scale, mRS);
Motorcortex excitability (Motor evoked potential, MEP; Resting motor threshold, RMT);
Quality of life (EuroQol 5D questionnaire, EQ-5D);

Three months after stroke:
Activities of daily living (Barthel-Index, BI) at admission and discharge in external rehabilitation facility;
Days of rehabilitation after intervention phase

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/04/04
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   90   Years
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Additional Inclusion Criteria

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

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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

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Addresses

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    • Universität zu Köln
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln
    • Mr.  Univ.-Prof. Dr.  Gereon  Fink 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln
    • Mr.  Dr.  Lukas  Hensel 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln
    • Kerpener Strasse 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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