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

June 26, 2011
August 1, 2011
August 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01407536 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients
Not Provided

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01407536
NSC-96-2314-B-037-028-MY3
No
Jau-Hong Lin/Professor, Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Science Council, Taiwan
  • National Health Research Institutes, Taiwan
  • Kaohsiung Medical University
Principal Investigator: Jau Hong Lin, PhD Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP