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

NCT01407536 | Completed Phase 1

• 1 other identifier: NSC-96-2314-B-037-028-MY3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Thermal Stimulation; Upper Extremity; Motor Recovery; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Transcranial Magnetic Stimulation

  Change from baseline in cortical excitability at post-1st-intervention, post-10th-intervention, post-20th-intervention and 1 month follow-up

Secondary Outcomes (4)

• Modified Ashworth Scale

  baseline, post-20th-intervention, 1 month follow-up

• Barthel Index

  baseline, post-20th-intervention, 1 month follow-up

• Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment

  baseline, post-20th-intervention, 1 month follow-up

• Thermal Quantitative Sensory Testing

  baseline, post-20th-intervention, 1 month follow-up

Interventions

Thermal stimulation system DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• National Health Research Institutes, Taiwan: collaborator
• Kaohsiung Medical University: collaborator

Study Sites (1)

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

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jau Hong Lin, PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2011
• First Posted: August 2, 2011
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 2, 2011

Record last verified: 2011-06

Locations

TW (1)