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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407536
• Other study ID #: NSC-96-2314-B-037-028-MY3
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 26, 2011
• Last updated: August 1, 2011
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2011
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan	Kaohsiung

Sponsors (4)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung Medical University, National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcranial Magnetic Stimulation		Change from baseline in cortical excitability at post-1st-intervention, post-10th-intervention, post-20th-intervention and 1 month follow-up	No
Secondary	Modified Ashworth Scale		baseline, post-20th-intervention, 1 month follow-up	No
Secondary	Barthel Index		baseline, post-20th-intervention, 1 month follow-up	No
Secondary	Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment		baseline, post-20th-intervention, 1 month follow-up	No
Secondary	Thermal Quantitative Sensory Testing		baseline, post-20th-intervention, 1 month follow-up	No