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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01407536
Enrollment
20
Registered
2011-08-02
Start date
2009-08-31
Completion date
2010-09-30
Last updated
2011-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

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

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.

Interventions

DEVICEThermal 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.

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Health Research Institutes, Taiwan
CollaboratorOTHER
Kaohsiung Medical University
CollaboratorOTHER
Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Transcranial Magnetic StimulationChange from baseline in cortical excitability at post-1st-intervention, post-10th-intervention, post-20th-intervention and 1 month follow-up

Secondary

MeasureTime frame
Modified Ashworth Scalebaseline, post-20th-intervention, 1 month follow-up
Barthel Indexbaseline, post-20th-intervention, 1 month follow-up
Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessmentbaseline, post-20th-intervention, 1 month follow-up
Thermal Quantitative Sensory Testingbaseline, post-20th-intervention, 1 month follow-up

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026