Theta-Burst-Stimulation in Recurrent Stroke Recovery

November 25, 2019 updated by: Christian Grefkes, University Hospital of Cologne
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

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
      • Cologne, Germany, 50937
        • Christian Grefkles

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
  • 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

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real-iTBS
Device: Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Device: Magstim Super Rapid2 System
Sham stimulation
Sham Comparator: Sham-iTBS
Device: Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Device: Magstim Super Rapid2 System
Sham stimulation

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
Relative grip force
Time Frame: After 8 days of intervention, and 3 months of enrollment
Grip force as measured with vigorimeter
After 8 days of intervention, and 3 months of enrollment
Motor function
Time Frame: After 8 days of intervention, and 3 months of enrollment
Action Research Arm Test, ARAT
After 8 days of intervention, and 3 months of enrollment
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
After 8 days of intervention, and 3 months of enrollment
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.
After 8 days of intervention, and 3 months of enrollment
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).
After 8 days of intervention, and 3 months of enrollment
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
After 8 days of intervention, and 3 months of enrollment
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
After 8 days of intervention, and 3 months of enrollment
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
After 8 days of intervention, and 3 months of enrollment
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.
After 8 days of intervention, and 3 months of enrollment
Quality of life
Time Frame: After 8 days of intervention, and 3 months of enrollment
EuroQol 5D questionnaire, EQ-5D
After 8 days of intervention, and 3 months of enrollment
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.
After 8 days of intervention, and 3 months of enrollment
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

Collaborators and Investigators

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

Sponsor

University Hospital of Cologne

Investigators

  • Principal Investigator: Christian Grefkes, MD, University Hospital Cologne

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)

January 11, 2018

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1204-6783

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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