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Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Thermal stimulation system
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Thermal Stimulation, Upper Extremity, Motor Recovery, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. first-ever stroke survivors with unilateral hemispheric lesions from a ischemic stroke.
  2. stroke onset more than 3 months
  3. no severe cognitive impairments and able to follow instructions
  4. the ability to sit on a chair for more than 30 minutes independently
  5. no family history of epilepsy

Exclusion Criteria:

  1. musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
  2. diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
  3. speech disorder or global aphasia;
  4. participating in any experimental rehabilitation or drug studies;
  5. skin injuries, burns, or fresh scars at the sites of stimulation;
  6. contraindication of heat or ice application

Sites / Locations

  • Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan

Outcomes

Primary Outcome Measures

Transcranial Magnetic Stimulation

Secondary Outcome Measures

Modified Ashworth Scale
Barthel Index
Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment
Thermal Quantitative Sensory Testing

Full Information

First Posted
June 26, 2011
Last Updated
August 1, 2011
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan, Kaohsiung Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01407536
Brief Title
Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan, Kaohsiung Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Functional magnetic resonance imaging (fMRI) has confirmed that thermal stimulation (TS) may facilitate cortical excitability in healthy adults. However, it is unknown whether TS can increase cortical excitability in stroke patients. Compared to the fMRI, the transcranial magnetic stimulation (TMS) possesses more concise conditions in temporal resolution, and it can present the cerebrum activation situation more instantaneously. This study aimed to use TMS examining the effect on corticomotor excitability, reorganization and functional motor recovery after TS on affected upper limbs of chronic stroke patients.
Detailed Description
The study was an assessor-blinded randomized controlled clinical trial. The participants (more than 3 months posts-stroke)were randomly assigned to experiment (EXP) and control (COT) groups. All participants received regular conventional rehabilitation programs. The EXP and COT received additional upper extremity TS protocol for 30 minutes a day for 20 days. The TS temperature of EXP for noxious stimulation was set at 46-47°C for heat and 7-8°C for cold stimulation; the temperature of COT for innoxious stimulation was set at 40°C for warm and 20°C for cold stimulation. The motor and sensory performance were evaluated at baseline and post-20th- TS by Brunnstrom's recovery stage, Modified Ashworth Scale (MAS), Barthel Index (BI), Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment (UE-FM) and Thermal Quantitative Sensory Testing (tQST). At pre-1st-TS, post-1st-TS, post-10th-TS and post-20th-TS, focal TMS was used to obtain measurement of motor threshold (MT), motor evoked potentials (MEPs), size of cortical motor output map and location of the amplitude-weighted centre of gravity of the motor output map (CoG) from abductor pollicis brevis (APB) in bilateral upper extremities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Thermal Stimulation, Upper Extremity, Motor Recovery, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Thermal stimulation system
Intervention Description
The subjects meeting our criteria will be randomly assigned to either the experimental group (EXP) or the control group (COT). The EXP and COT received upper extremity thermal stimulation protocol for 30 minutes a day for 20 days. The TS temperature of EXP for noxious stimulation was set at 46-47°C for heat and 7-8°C for cold stimulation; the temperature of COT for innoxious stimulation was set at 40°C for warm and 20°C for cold stimulation.
Primary Outcome Measure Information:
Title
Transcranial Magnetic Stimulation
Time Frame
Change from baseline in cortical excitability at post-1st-intervention, post-10th-intervention, post-20th-intervention and 1 month follow-up
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Time Frame
baseline, post-20th-intervention, 1 month follow-up
Title
Barthel Index
Time Frame
baseline, post-20th-intervention, 1 month follow-up
Title
Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment
Time Frame
baseline, post-20th-intervention, 1 month follow-up
Title
Thermal Quantitative Sensory Testing
Time Frame
baseline, post-20th-intervention, 1 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first-ever stroke survivors with unilateral hemispheric lesions from a ischemic stroke. stroke onset more than 3 months no severe cognitive impairments and able to follow instructions the ability to sit on a chair for more than 30 minutes independently no family history of epilepsy Exclusion Criteria: musculoskeletal or cardiac disorders that could potentially interfere with experimental tests; diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy; speech disorder or global aphasia; participating in any experimental rehabilitation or drug studies; skin injuries, burns, or fresh scars at the sites of stimulation; contraindication of heat or ice application
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau Hong Lin, PhD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

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Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients

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