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

This study has been completed.
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Kaohsiung Medical University
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01407536
First received: June 26, 2011
Last updated: August 1, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Stroke
Device: Thermal stimulation system
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Ashworth Scale [ Time Frame: baseline, post-20th-intervention, 1 month follow-up ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: baseline, post-20th-intervention, 1 month follow-up ] [ Designated as safety issue: No ]
  • Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment [ Time Frame: baseline, post-20th-intervention, 1 month follow-up ] [ Designated as safety issue: No ]
  • Thermal Quantitative Sensory Testing [ Time Frame: baseline, post-20th-intervention, 1 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Thermal stimulation system
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407536

Locations
Taiwan
Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan
Kaohsiung, Taiwan
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Kaohsiung Medical University
Investigators
Principal Investigator: Jau Hong Lin, PhD Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Jau-Hong Lin/Professor, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT01407536     History of Changes
Other Study ID Numbers: NSC-96-2314-B-037-028-MY3
Study First Received: June 26, 2011
Last Updated: August 1, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Stroke
Thermal Stimulation
Upper Extremity
Motor Recovery
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014