search
Back to results

Theta-Burst-Stimulation in Recurrent Stroke Recovery

Primary Purpose

Stroke, Neurorehabilitation

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Magstim Super Rapid2 System
Magstim Super Rapid2 System
Sponsored by
University Hospital of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Recurrent stroke, Stroke, Transcranial Magnetic Stimulation, Theta-Burst-Stimulation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christian Grefkles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real-iTBS

Sham-iTBS

Arm Description

Outcomes

Primary Outcome Measures

Relative grip force
grip force as measured with vigorimeter

Secondary Outcome Measures

Relative grip force
Grip force as measured with vigorimeter
Motor function
Action Research Arm Test, ARAT
Motor function
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
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
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
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
Motor cortex excitability/ Resting motor threshold
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
Motor cortex excitability/ Short-interval intracortical inhibition
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
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
EuroQol 5D questionnaire, EQ-5D
Activities of daily living at admission and discharge in external rehabilitation facility
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
Days of rehabilitation after intervention phase as documented by external rehabilitation facility

Full Information

First Posted
November 3, 2017
Last Updated
November 25, 2019
Sponsor
University Hospital of Cologne
search

1. Study Identification

Unique Protocol Identification Number
NCT03337867
Brief Title
Theta-Burst-Stimulation in Recurrent Stroke Recovery
Official Title
Theta-Burst-Stimulation in Recurrent Stroke Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neurorehabilitation
Keywords
Recurrent stroke, Stroke, Transcranial Magnetic Stimulation, Theta-Burst-Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real-iTBS
Arm Type
Active Comparator
Arm Title
Sham-iTBS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Magstim Super Rapid2 System
Intervention Description
Intermittent theta-burst-stimulation (iTBS) protocol
Intervention Type
Device
Intervention Name(s)
Magstim Super Rapid2 System
Intervention Description
Sham stimulation
Primary Outcome Measure Information:
Title
Relative grip force
Description
grip force as measured with vigorimeter
Time Frame
3 months after enrollment
Secondary Outcome Measure Information:
Title
Relative grip force
Description
Grip force as measured with vigorimeter
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Motor function
Description
Action Research Arm Test, ARAT
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Motor function
Description
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
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Stroke severity
Description
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.
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Degree of disability
Description
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Motor cortex excitability/ Motor evoked potential
Description
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Motor cortex excitability/ Resting motor threshold
Description
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Motor cortex excitability/ Short-interval intracortical inhibition
Description
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
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Motor cortex excitability/ Ipsilateral silent period
Description
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.
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Quality of life
Description
EuroQol 5D questionnaire, EQ-5D
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Activities of daily living at admission and discharge in external rehabilitation facility
Description
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.
Time Frame
After 8 days of intervention, and 3 months of enrollment
Title
Days of rehabilitation after intervention phase
Description
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
Time Frame
3 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Grefkes, MD
Organizational Affiliation
University Hospital Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christian Grefkles
City
Cologne
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Theta-Burst-Stimulation in Recurrent Stroke Recovery

We'll reach out to this number within 24 hrs