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Theta-Burst-Stimulation in Recurrent Stroke Recovery

This study is not yet open for participant recruitment.
Verified November 2017 by Christian Grefkes, University Hospital of Cologne
Sponsor:
ClinicalTrials.gov Identifier:
NCT03337867
First Posted: November 9, 2017
Last Update Posted: November 10, 2017
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.
Information provided by (Responsible Party):
Christian Grefkes, University Hospital of Cologne
  Purpose
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.

Condition Intervention Phase
Stroke Neurorehabilitation Device: Magstim Super Rapid2 System Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Theta-Burst-Stimulation in Recurrent Stroke Recovery

Further study details as provided by Christian Grefkes, University Hospital of Cologne:

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


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

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

  • Motor function [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]

    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


  • Stroke severity [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]

    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.


  • Degree of disability [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]
    Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).

  • Motor cortex excitability/ Motor evoked potential [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]
    Motor evoked potential (MEP) induced by stimulation of the affected motor cortex

  • Motor cortex excitability/ Resting motor threshold [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]
    Resting motor threshold as measured by stimulation of the affected motor cortex, RMT

  • Motor cortex excitability/ Short-interval intracortical inhibition [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]
    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

  • Motor cortex excitability/ Ipsilateral silent period [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]
    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.

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

  • Activities of daily living at admission and discharge in external rehabilitation facility [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]
    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.

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


Estimated Enrollment: 60
Anticipated Study Start Date: November 13, 2017
Estimated Study Completion Date: February 1, 2020
Estimated Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real-iTBS Device: Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Sham Comparator: Sham-iTBS Device: Magstim Super Rapid2 System
Sham stimulation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Christian Grefkes, Principal Investigator, Professor, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT03337867     History of Changes
Other Study ID Numbers: U1111-1204-6783
First Submitted: November 3, 2017
First Posted: November 9, 2017
Last Update Posted: November 10, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christian Grefkes, University Hospital of Cologne:
Recurrent stroke
Stroke
Transcranial Magnetic Stimulation
Theta-Burst-Stimulation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases