AcupunctureNCT03501004
The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders
A study testing Sterile acupuncture needles for single use in people with Acupuncture and Parkinson's Disease, run by Tsinghua University at 1 site in China.
Trial summary
The purpose of the study is to compare vascular and functional neurological changes of acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Acupuncture, Parkinson's Disease, Sleep Disorders
- What is being tested?
- Sterile acupuncture needles for single use
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Sep 2020
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meeting the above diagnostic criteria for Parkinson's disease and Sleep Disorders;
- Hoehn-Yahr grade 2-3;
- Those who voluntarily participate in the project while he/she or his/her guardian sign an informed consent form;
- Those who have had a junior high school education or above and have a correct understanding of clinical acupuncture research significance.
Who cannot join
- Accompanied with sleep apnea syndrome, sleep-behavioral disorders such as sleep-breathing disorders, and other system diseases that cause sleep disorders, such as anemia and other hematological diseases, hypothyroidism, severe heart and lung diseases, tumors, liver and kidney diseases;
- History of drug use or alcohol addiction, psychosis and sedation for painful illnesses;
- Severe cognitive impairments and failure to complete scale assessments;
- There are barriers to communication and communication that affect the evaluation of research, such as speech, vision, hearing and other serious damage to patients;
- Allergic to needles or alcohol;
- Those who cannot perform MRI scans, such as claustrophobia.
Trial locations and contacts
1 site in 1 country.
China1 site
Tsinghua University Yuquan Hospital
Beijing, Beijing Municipality, 100000
About this study
The purpose of the study is to compare vascular and functional neurological changes of acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints GV14（Dazhui）and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi) in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the study, researchers will observe changes in cerebral blood vessels and neuroimaging before and after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal imaging techniques could evaluate the effect of acupuncture on brain blood vessels and function in patients with Parkinson's disease and Sleep Disorders and provide an objective neuroimaging basis for assessing the effectiveness of acupuncture.
Read the detailed description
Neuroimaging assessment:Subjects are keeping awake, resting flat on the examination table, using rubber earplugs to reduce noise, using foam headbands to fix head movement artifacts, closing eyes to calm breathing, fixing the head and minimizing head and other parts of the initiative and passive exercise.At the same time, it is required not to carry out any thinking activities. After the subject is familiar with the environment, it begins to scan and conduct a comprehensive MRI scan before and after the acupuncture needling.
- Conditions
- Acupuncture, Parkinson's Disease, Sleep Disorders, Neuroimaging
- Being tested
- Sterile acupuncture needles for single use
- Medical subject headings
- Parkinson Disease, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile acupuncture needles for single useDevice
Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm.
| Study group | Role | What they receive |
|---|---|---|
| The Acupuncture Group | Experimental | Sterile acupuncture needles for single use will be used.The intervention is going to be executed using the acupuncture points GV14（Dazhui）and GB20 (Fengchi) for 20 minutes.The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi). Receives: Device: Sterile acupuncture needles for single use |
| The Sham Acupuncture Group | Sham comparator | Sterile acupuncture needles for single use will be used.The sham acupuncture group's acupuncture needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points for 20 minutes. Receives: Device: Sterile acupuncture needles for single use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow data change
Neuroimaging assessment by 3D SNAP-MRA
Measured: Through once acupuncture completion, 30 minutes
Secondary outcomes (4)
Parkinson's Disease Sleep Scale
Scale evaluation.Scale Range:0-150.Higher values represent a better outcome.
Measured: Through once acupuncture completion, 30 minutes
Pittsburgh Sleep Quality Index
Scale evaluation.Scale Range:0-21.Higher values represent a worse outcome.
Measured: Through once acupuncture completion, 30 minutes
Epworth Sleepiness Scale
Scale evaluation.Scale Range:0-24.Higher values represent a worse outcome.
Measured: Through once acupuncture completion, 30 minutes
Unified Parkinson's Disease Rating Scale
Scale evaluation.Scale Range:0-149.Higher values represent a worse outcome.
Measured: Through once acupuncture completion, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Ma, Tsinghua University
- Investigators
- Yuqi Zhang, Study chair, Tsinghua University Yuquan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501004
- Sponsor's protocol ID
- QHDXYQYY20180001
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2018
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders
- ClinicalTrials.gov ID
- NCT03501004
- Acronym / sponsor ID
- QHDXYQYY20180001
- Conditions
- Acupuncture, Parkinson's Disease, Sleep Disorders, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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 purpose of the study is to compare vascular and functional neurological changes of acupuncture in patients with Parkinson's Disease and Sleep Disorders. In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints GV14（Dazhui）and GB20 (Fengchi).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi) in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points.During the study, researchers will observe changes in cerebral blood vessels and neuroimaging before and after acupuncture in the two groups. Using multimodal fusion advanced vascular-neuronal imaging techniques could evaluate the effect of acupuncture on brain blood vessels and function in patients with Parkinson's disease and Sleep Disorders and provide an objective neuroimaging basis for assessing the effectiveness of acupuncture.
Detailed description
Neuroimaging assessment:Subjects are keeping awake, resting flat on the examination table, using rubber earplugs to reduce noise, using foam headbands to fix head movement artifacts, closing eyes to calm breathing, fixing the head and minimizing head and other parts of the initiative and passive exercise.At the same time, it is required not to carry out any thinking activities. After the subject is familiar with the environment, it begins to scan and conduct a comprehensive MRI scan before and after the acupuncture needling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Acupuncture Group | Experimental | Device: Sterile acupuncture needles for single useSterile acupuncture needles for single use will be used.The intervention is going to be executed using the acupuncture points GV14（Dazhui）and GB20 (Fengchi) for 20 minutes.The acupuncture needles will be inserted to a depth of 0.8 to 1 cm using GV14（Dazhui）and GB20 (Fengchi). |
| The Sham Acupuncture Group | Sham comparator | Device: Sterile acupuncture needles for single useSterile acupuncture needles for single use will be used.The sham acupuncture group's acupuncture needles will be inserted to a depth of 0.1 to 0.2 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points for 20 minutes. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meeting the above diagnostic criteria for Parkinson's disease and Sleep Disorders;
- Hoehn-Yahr grade 2-3;
- Those who voluntarily participate in the project while he/she or his/her guardian sign an informed consent form;
- Those who have had a junior high school education or above and have a correct understanding of clinical acupuncture research significance.
Key exclusion criteria (6 listed)
- Accompanied with sleep apnea syndrome, sleep-behavioral disorders such as sleep-breathing disorders, and other system diseases that cause sleep disorders, such as anemia and other hematological diseases, hypothyroidism, severe heart and lung diseases, tumors, liver and kidney diseases;
- History of drug use or alcohol addiction, psychosis and sedation for painful illnesses;
- Severe cognitive impairments and failure to complete scale assessments;
- There are barriers to communication and communication that affect the evaluation of research, such as speech, vision, hearing and other serious damage to patients;
- Allergic to needles or alcohol;
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 |
|---|---|---|
| Sterile acupuncture needles for single useSterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm. | Device | The Acupuncture Group, The Sham Acupuncture Group |
Primary outcome
Cerebral blood flow data change
Time frame: Through once acupuncture completion, 30 minutes
Neuroimaging assessment by 3D SNAP-MRA
4 secondary outcomes
Parkinson's Disease Sleep Scale
Time frame: Through once acupuncture completion, 30 minutes
Pittsburgh Sleep Quality Index
Time frame: Through once acupuncture completion, 30 minutes
Epworth Sleepiness Scale
Time frame: Through once acupuncture completion, 30 minutes
Unified Parkinson's Disease Rating Scale
Time frame: Through once acupuncture completion, 30 minutes
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 12 Apr 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Yuqi Zhang study chair
Tsinghua University Yuquan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile acupuncture needles for single use in people with Acupuncture and Parkinson's Disease, run by Tsinghua University at 1 site in China.
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 4 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 12 Apr 2021. 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 China. 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.
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?
Cerebral blood flow data change (time frame: Through once acupuncture completion, 30 minutes). 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 12 Apr 2021.