Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients
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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 |
- 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 ]
- 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) |
-
Device: Thermal stimulation system
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 |
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
Contacts and Locations| Taiwan | |
| Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan | |
| Kaohsiung, Taiwan | |
| 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:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 17, 2013