Clinical trial NCT01407536: Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Stroke
Thermal Stimulation
Upper Extremity
Motor Recovery
Transcranial Magnetic Stimulation
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
name: Kaohsiung Medical University
First posted: 2011-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Transcranial Magnetic Stimulation
timeFrame: Change from baseline in cortical excitability at post-1st-intervention, post-10th-intervention, post-20th-intervention and 1 month follow-up
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: baseline, post-20th-intervention, 1 month follow-up
measure: Barthel Index
timeFrame: baseline, post-20th-intervention, 1 month follow-up
measure: Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment
timeFrame: baseline, post-20th-intervention, 1 month follow-up
measure: Thermal Quantitative Sensory Testing
timeFrame: baseline, post-20th-intervention, 1 month follow-up
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Physical Therapy, Kaohsiung Medical University, Kaohsiung, Taiwan
Study officials:
affiliation: Kaohsiung Medical University
name: Jau Hong Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: