StrokePhase 1NCT02197663
Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
A Phase 1 study testing acupuncture(44mm in length and 32-gauge) in people with Stroke, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The lifestyle of Taiwanese people has been changed over the past decade with the improvement of economic growth, environmental sanitation and the quality of medical care. Now the investigators pay more attention to the increasing risk of people's diseases of civilization than people's malnutrition and poor quality of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- acupuncture(44mm in length and 32-gauge)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Jul 2015
- Phase
- Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia
Who cannot join
- transient ischemic attack
- brain tumor, brain trauma
- recurrent stroke
- multiple organs failure, cancer
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Acupuncture, China Medical University Hospital
Taichung
About this study
The lifestyle of Taiwanese people has been changed over the past decade with the improvement of economic growth, environmental sanitation and the quality of medical care. Now the investigators pay more attention to the increasing risk of people's diseases of civilization than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the patient of cerebrovascular accident cause a lot of money and is a burden of our country.
Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with cerebrovascular accident. The investigators use some scales to assess efficacy of acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.
Read more
Besides, the investigators notice that there are few journals about acupuncture effect of treating depression following cerebral vascular accident. The investigators may underestimate the amount of people having post-stroke depression. So the investigators use Hamilton Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident patient.
By assessing bio-psycho-social level of CVA patient, the investigators hope this study will offer them more "Holistic Health Care".
Read the detailed description
We want to assess the effect of acupuncture on stroke patients. The study is a double-blind randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:
(1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia
Exclusion Criteria:
(1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last time of treatment). The course of treatment should be completed within 3 months.
- Conditions
- Stroke
- Being tested
- acupuncture(44mm in length and 32-gauge)
- Keywords
- acupuncture, stroke, Randomized Controlled Trial
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture(44mm in length and 32-gauge)Procedure or surgery
Also called acupuncture(4.4cm in length and 32-gauge), shame acupuncture(1.27 cm in length and 40-gauge)
The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. Receives: Procedure: acupuncture(44mm in length and 32-gauge) |
| sham acupuncture | Sham comparator | The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen. Receives: Procedure: acupuncture(44mm in length and 32-gauge) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Barthel index at 8 weeks
Measured: Baseline and 8 weeks
Change from baseline in Barthel Index at 16 weeks
Measured: Baseline, 16 weeks
Change from baseline in Barthel Index at 24 weeks
Measured: Baseline, 24 weeks
Change from baseline in National Institute of Health Stroke Scale at 8 weeks
Measured: Baseline, 8 weeks
Change from baseline in National Institute of Health Stroke Scale at 16 weeks
Measured: Baseline, 16 weeks
Change from baseline in National Institute of Health Stroke Scale at 24 weeks
Measured: Baseline, 24 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks
Measured: Baseline, 8 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks
Measured: Baseline, 16 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks
Measured: Baseline, 24 weeks
Change from baseline in Hamilton Depression Rating Scale at 8 weeks
Measured: Baseline, 8 weeks
Change from baseline in Hamilton Depression Rating Scale at 16 weeks
Measured: Baseline,16 weeks
Change from baseline in Hamilton Depression Rating Scale at 24 weeks
Measured: Baseline, 24 weeks
Secondary outcomes (3)
Change from baseline in Visual Analogue Scale at 8 weeks
Measured: Baseline, 8 weeks
Change from baseline in Visual Analogue Scale at 16 weeks
Measured: Baseline,16 weeks
Change from baseline in Visual Analogue Scale at 24 weeks
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: the numbers of drop-out patients are more than we anticipate
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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chen Lee, PHD, Study director, Department of Acupuncture, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197663
- Sponsor's protocol ID
- CMUH102-REC2-015
- Status last verified
- Oct 2015
- First submitted
- 8 Jun 2014
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
- ClinicalTrials.gov ID
- NCT02197663
- Acronym / sponsor ID
- CMUH102-REC2-015
- Conditions
- Stroke
- Keywords
- acupuncture, stroke, Randomized Controlled Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the numbers of drop-out patients are more than we anticipate
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jul 2014 (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.
The lifestyle of Taiwanese people has been changed over the past decade with the improvement of economic growth, environmental sanitation and the quality of medical care. Now the investigators pay more attention to the increasing risk of people's diseases of civilization than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the patient of cerebrovascular accident cause a lot of money and is a burden of our country.
Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with cerebrovascular accident. The investigators use some scales to assess efficacy of acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.
Besides, the investigators notice that there are few journals about acupuncture effect of treating depression following cerebral vascular accident. The investigators may underestimate the amount of people having post-stroke depression. So the investigators use Hamilton Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident patient.
By assessing bio-psycho-social level of CVA patient, the investigators hope this study will offer them more "Holistic Health Care".
Detailed description
We want to assess the effect of acupuncture on stroke patients. The study is a double-blind randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:
(1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia
Exclusion Criteria:
(1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.
The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last time of treatment). The course of treatment should be completed within 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: acupuncture(44mm in length and 32-gauge)The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. |
| sham acupuncture | Sham comparator | Procedure: acupuncture(44mm in length and 32-gauge)The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia
Key exclusion criteria (4 listed)
- transient ischemic attack
- brain tumor, brain trauma
- recurrent stroke
- multiple organs failure, cancer
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 |
|---|---|---|
| acupuncture(44mm in length and 32-gauge)Also: acupuncture(4.4cm in length and 32-gauge), shame acupuncture(1.27 cm in length and 40-gauge)The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen. | Procedure or surgery | Acupuncture, sham acupuncture |
Primary outcome
Change from baseline in Barthel index at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline in Barthel Index at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline in Barthel Index at 24 weeks
Time frame: Baseline, 24 weeks
Change from baseline in National Institute of Health Stroke Scale at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline in National Institute of Health Stroke Scale at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline in National Institute of Health Stroke Scale at 24 weeks
Time frame: Baseline, 24 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks
Time frame: Baseline, 24 weeks
Change from baseline in Hamilton Depression Rating Scale at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline in Hamilton Depression Rating Scale at 16 weeks
Time frame: Baseline,16 weeks
Change from baseline in Hamilton Depression Rating Scale at 24 weeks
Time frame: Baseline, 24 weeks
3 secondary outcomes
Change from baseline in Visual Analogue Scale at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline in Visual Analogue Scale at 16 weeks
Time frame: Baseline,16 weeks
Change from baseline in Visual Analogue Scale at 24 weeks
Time frame: Baseline, 24 weeks
Results and safety
The study was stopped early (reason given: the numbers of drop-out patients are more than we anticipate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Yu-Chen Lee, PHD study director
Department of Acupuncture, China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acupuncture(44mm in length and 32-gauge) in people with Stroke, run by China Medical University 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Oct 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 was stopped early (reason given: the numbers of drop-out patients are more than we anticipate). Results are not available in the source record.
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?
Change from baseline in Barthel index at 8 weeks (time frame: Baseline and 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2015.