StrokePhase 1/2NCT01407536

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

A Phase 1/2 study testing Thermal stimulation system in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke
What is being tested?: Thermal stimulation system
Type of treatment: Medical device
How many people: 20 participants
Where: 1 siteTaiwan
Study dates: Aug 2009to Sep 2010
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

Other trials in Taiwan

About this study

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.

Read the 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
Being tested: Thermal stimulation system
Keywords: Stroke, Thermal Stimulation, Upper Extremity, Motor Recovery, Transcranial Magnetic Stimulation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thermal stimulation systemDevice
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Transcranial Magnetic Stimulation
Measured: 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
Measured: baseline, post-20th-intervention, 1 month follow-up
Barthel Index
Measured: baseline, post-20th-intervention, 1 month follow-up
Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment
Measured: baseline, post-20th-intervention, 1 month follow-up
Thermal Quantitative Sensory Testing
Measured: baseline, post-20th-intervention, 1 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Sep 2010

First posted2 Aug 2011 (estimated)
Study startAug 2009
Primary completionJun 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01407536
Sponsor's protocol ID: NSC-96-2314-B-037-028-MY3
Status last verified: Jun 2011
First submitted: 26 Jun 2011
Last updated: 2 Aug 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients
ClinicalTrials.gov ID: NCT01407536
Acronym / sponsor ID: NSC-96-2314-B-037-028-MY3
Conditions: Stroke
Keywords: Stroke, Thermal Stimulation, Upper Extremity, Motor Recovery, Transcranial Magnetic Stimulation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (estimated)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
Collaborators: National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan, Kaohsiung Medical University
Study start: Aug 2009
Primary completion: Jun 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 2 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thermal stimulation systemThe 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.	Device	–

Primary outcome

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

4 secondary outcomes

Modified Ashworth Scale
Time frame: baseline, post-20th-intervention, 1 month follow-up
Barthel Index
Time frame: baseline, post-20th-intervention, 1 month follow-up
Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment
Time frame: baseline, post-20th-intervention, 1 month follow-up
Thermal Quantitative Sensory Testing
Time frame: baseline, post-20th-intervention, 1 month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.

Related trials for Stroke

Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jau Hong Lin, PhD principal investigator

Kaohsiung Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Thermal stimulation system in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.