Individualized rTMS Protocol for Stroke Recovery

January 31, 2019 updated by: Chang Gung Memorial Hospital

Development and Efficacy Evaluation of Individualized rTMS Protocol for Stroke Recovery

This study aims to develop individualized therapeutic protocol to improve stroke recovery and fits the scheme of Mechanisms, biomarkers, and treatment strategies for stroke, aging, and Parkinson's disease by advanced EEG analysis and transcranial magnetic stimulation technique.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It has long been a challenge to promote the recovery after stroke. So far, rehabilitation has been the most evident way for this purpose, while pharmacological approaches have done very little.

However, the unsatisfied results urge us to recognize the need of new therapeutic solutions for stroke recovery. In the past few years, the development of non-invasive brain stimulation techniques, which are capable of altering the brain excitability through plasticity-like mechanisms for up to an hour or so, lead to the expectation of improving the recovery of stroke and other neurological disorders by manipulation neuroplasticity. Nevertheless, even with the help of brain stimulation, the results in stroke recovery are diverse and limited, although most studies agree that non-invasive brain stimulation, including repetitive transcranial magnetic stimulation (rTMS) is beneficial to the recovery after stroke.

Therefore, it is an important topic to ameliorate the recipe of brain stimulation for stroke recovery to improve its efficiency and efficacy. Facing this challenge, the investigators designed this study to develop individualized rTMS protocol for stroke recovery, to verify the predictor of stroke outcome discovered by DCM and to explore factors that cause the variability of rTMS. Based on our recent findings that revealed key patterns of stroke recovery base in EEG-based EEG based dynamic causal modelling (DCM), the individualize TMS protocol will be developed. The investigators will first apply different protocols of rTMS given to a variety of locations within the motor network to evaluate their effects on the DCM network. The results will be used for selecting proper rTMS protocols for stroke patients based on their DCM results. The effect of the individualized rTMS protocol will be tested in a small group of patient first. Then the longer therapeutic effect of the protocol will be assessed in a larger patient group under a double-blinded randomized control basis. With the help of this project, the investigators will be able to understand how different protocols of rTMS given to a variety of locations within the motor network affect the DCM network. Such information will be useful for developing individualized rTMS protocol for not only stroke therapy in the present study, but also other neurological disorders, e.g. Parkinson's disease and dystonia, in the further studies.

Furthermore, the investigators expect that the patients stimulated with rTMS using the protocol matched to their DCM network will recover better than those treated with unmatched protocol. This part of result could be further applied as a clinical application to facilitate stroke recovery. The predictors for stroke recovery revealed by the DCM model will also be verified in the current project. This will give us more information about the accuracy of the predictors and may give us new insights for the further development of stroke therapy. The investigators will further analyze EEG data and the results to provide knowledge of the state-dependent effect of brain on the variability of the current forms of rTMS and other noninvasive brain stimulation. This part of information will be very helpful for developing the strategy for eliminating the variability of rTMS and for improving the protocol of rTMS to be more powerful and efficient.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

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

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Ying-Zu Huang
        • Contact:
          • Ying-Zu Huang, MD, PhD
        • Sub-Investigator:
          • CC Chen

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first-ever stroke
  • in subacute stage (between 1-3 months after stroke onset)
  • monohemispheric ischemic stroke
  • able to follow the command of the shoulder flexion
  • mild to moderate paresis in the upper limb (the motor arm score of National Institute of Health Stroke Scale (NIHSS) = 1 & 2 out of 4, where 4 = no movement)

Exclusion Criteria:

  • being less than 20 years or over 75 years of age
  • history of seizures or epileptiform discharges on electroencephalogram (EEG)
  • pregnancy
  • aphasia, apraxia, and concomitant neurological diseases or other severe medical diseases (e.g., sepsis, malignancy, hepatic or renal failure).
  • having a pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (for example after brain surgery or a shrapnel wound)
  • taking tricyclic antidepressants, neuroleptic agents and other drugs that lower the seizure threshold
  • Insulin dependent diabetes
  • Thyroid disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy control
This group does not undergo any treatment . Intervention : rTMS
Device: rTMS
Magnetic stimulation will be given using a hand-held figure-of-eight coil with an median winding diameter of 70 mm or a cone coil (Magstim Co., Whitland, Dyfed, UK) connected to one Magstim Rapid2 Package (Magstim Co., UK). The figure-of-eight coil will be placed tangentially to the scalp with the handle pointing backwards, which is thought to preferentially activate the corticospinal cells trans-synaptically (Kaneko et al., 1996), while the cone coil will be placed along the anterioposterior axis to induce a posterior-to-anterior current in the cortex.
Experimental: stroke patient

this group undergoes rehabilitative therapy. It is a 24-week program and stroke patients practice the physical exercise for 1 hour each time. The intensity is three times a week.

Intervention : rTMS
Device: rTMS
Magnetic stimulation will be given using a hand-held figure-of-eight coil with an median winding diameter of 70 mm or a cone coil (Magstim Co., Whitland, Dyfed, UK) connected to one Magstim Rapid2 Package (Magstim Co., UK). The figure-of-eight coil will be placed tangentially to the scalp with the handle pointing backwards, which is thought to preferentially activate the corticospinal cells trans-synaptically (Kaneko et al., 1996), while the cone coil will be placed along the anterioposterior axis to induce a posterior-to-anterior current in the cortex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of Fugl-Meyer Assessment of Physical Performance (FM)
Time Frame: upon recruitment, after 24 weeks of rehabilitation treatment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
upon recruitment, after 24 weeks of rehabilitation treatment
The changes of upper extremity performance evaluation test for the elderly (TEMPA)
Time Frame: upon recruitment, after 24 weeks of rehabilitation treatment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
upon recruitment, after 24 weeks of rehabilitation treatment
The changes of Wolf Motor Function Test (WMFT)
Time Frame: upon recruitment, after 24 weeks of rehabilitation treatment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
upon recruitment, after 24 weeks of rehabilitation treatment

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

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)

April 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-2292A3

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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