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

NCT ID: NCT01407536

Last Updated: 2011-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kaohsiung Medical University

Principal Investigators

Jau Hong Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

NSC-96-2314-B-037-028-MY3

Identifier Type: -

Identifier Source: org_study_id