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Completed

NCT Number: NCT01407536

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: baseline, post-20th-intervention, 1 month follow-up

  2. Barthel Index

    Time frame: baseline, post-20th-intervention, 1 month follow-up

  3. Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment

    Time frame: baseline, post-20th-intervention, 1 month follow-up

  4. Thermal Quantitative Sensory Testing

    Time frame: baseline, post-20th-intervention, 1 month follow-up

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Kaohsiung Medical University
  • National Health Research Institutes, Taiwan
  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 2, 2011
Registry last updated
Aug 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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