NCT03828435

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

January 27, 2016

Last Update Submit

January 31, 2019

Conditions

Stroke

Keywords

patient

Outcome Measures

Primary Outcomes (3)

  • The changes of Fugl-Meyer Assessment of Physical Performance (FM)

    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)

    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)

    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

Study Arms (2)

healthy control

EXPERIMENTAL

This group does not undergo any treatment . Intervention : rTMS

Device: rTMS

stroke patient

EXPERIMENTAL

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

Interventions

rTMSDEVICE

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.

healthy controlstroke patient

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ying-Zu Huang

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Ying-Zu Huang, MD, PhD

CONTACT

+886 3 3281200yzhuang@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 4, 2019

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

TW(1)