Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Multicenter Clinical Study Protocol for Acupuncture Treatment of Early Parkinson's Disease with Mild Cognitive Impairment

Registration number：

ITMCTR2025000567

Date of Last Refreshed on：

2025-03-22

Date of Registration：

2025-03-22

Registration Status：

Prospective registration

Public title：

Multicenter Clinical Study Protocol for Acupuncture Treatment of Early Parkinson's Disease with Mild Cognitive Impairment

English Acronym：

Scientific title：

Multicenter Clinical Study Protocol for Acupuncture Treatment of Early Parkinson's Disease with Mild Cognitive Impairment

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Peng Chen

Study leader：

Peng Chen

Applicant telephone：

13810830776

Study leader's telephone：

13810830776

Applicant Fax：

Study leader's fax：

Applicant E-mail：

chenpenger@126.com

Study leader's E-mail：

chenpenger@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 23 Post-Street of Art Gallery Dongcheng District Beijing

Study leader's address：

No. 23 Post-Street of Art Gallery Dongcheng District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing Hospital of Tradional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2025BL02-013-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine Capital Medical University

Date of approved by ethic committee：

2025/3/3 0:00:00

Contact Name of the ethic committee：

Sheng Liu

Contact Address of the ethic committee：

No.23 Post-Street of Art Gallery Dongcheng District Beijing

Contact phone of the ethic committee：

010-87906734

Contact email of the ethic committee：

liusheng4377@163.com

Primary sponsor：

Beijing Hospital of Tradional Chinese Medicine

Primary sponsor's address：

No. 23 Post-Street of Art Gallery Dongcheng District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Beijing

Institution
hospital：

Beijing Hospital of Tradional Chinese Medicine

Address：

No. 23 Post-Street of Art Gallery Dongcheng District Beijing

Source(s) of funding：

Self-financed

Target disease：

Parkinson's disease

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To evaluate the efficacy and safety of acupuncture in the treatment of early PD with mild cognitive impairment (MCI) and to provide scientific basis for acupuncture treatment of PD.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1)It meets the diagnostic criteria of the PD-MCI comprehensive assessment model in the Chinese guidelines for the diagnosis and treatment of mild cognitive impairment in Parkinson's disease (2020 edition); (2)Age 50 to 75; (3)Montreal cognitive assessment scale score ≥20 and ≤25; (4)Have received standardized medication for at least 3 months have fixed anti-PD drug treatment plan no drug adjustment plan in the next 3 months; (5)H-Y stage ≤2.5 grade -LRB-grade 1: symptoms of unilateral limb involvement; grade 1.5: symptoms of unilateral limb involvement with trunk involvemeGraderade 2: symptoms of bilateral limb involvement with no balance impairmeGraderade 2.5: mild bilateral limb involvement with mild balance impairmeGraderade 3: moderate bilateral limb involvement with significant postural instability with many functional limitations in the patient but ability to fend for himself and slow turning; grade 4: severe bilateral limb involvement with difficulty walking or standing independently; gradeBedriddendden or living in a wheelchair. Grades 1-2.5 are in patients with early PD grades 3-4 in patients with intermediate PD and grades 5 in patients with advanced PD; (6)I have not received acupuncture treatment for PD-MCI or PD in the last 3 months; (7)Sign an informed consent form.

Exclusion criteria：

(1)Secondary Parkinson syndrome or Parkinson's plus syndrome; (2)People with Alzheimer's disease Parkinson's disease dementia cerebrovascular disease severe diabetes traumatic brain injury as well as drugs and alcohol can explain cognitive impairment and other serious mental illnesses; (3)Is currently taking or has taken a medication in the past 3 months that improves cognitive function examples include cholinesterase inhibitors (rivastigmine donepezil and galantamine) memantine or over-the-counter drugs that claim cognitive benefits; (4)Patients treated with neurosurgery (deep brain stimulation) psychotherapy or repetitive transcranial magnetic stimulation; (5)Patients with depression Beck Depression Inventory-II ≥20; (6)Patients participating in other clinical trials.

Study execute time：

From 2025-01-01

To      2027-12-31

Recruiting time：

From 2025-04-01

To      2026-12-31

Interventions：

48

Group：

control group

Sample size：

Intervention：

sham acupuncture

Intervention code：

48

Group：

treatment group

Sample size：

Intervention：

acupuncture

Intervention code：

Total sample size ： 96

Countries of recruitment
and research settings：

Country：

China

Province：

Hebei Province

City：

Qinhuangdao

Institution/hospital：

Hebei Rehabilitation Hospital

Level of the institution：

second level

Country：

China

Province：

Hebei Province

City：

Tangshan

Institution/hospital：

Yutian County Hebei Chinese Medicine Hospital

Level of the institution：

Tertiary level

Country：

China

Province：

Beijing

City：

Beijing

Institution/hospital：

Beijing Hospital of Tradional Chinese Medicine

Level of the institution：

3A

Outcomes：

Outcome：

verbal fluency test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Montreal cognitive assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Verbal fluency test

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Rey auditory word learning test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Unified Parkinson's disease rating scalesection Ⅲ

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

clock drawing test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Proportion of patients with H-Y stage more advanced than at enrollment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TMT-A

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

clock drawing test

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Parkinson's Disease Questionnaire-39

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hooper visual organization test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Boston naming test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

50
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study used a multicenter Randomized controlled trial design with a sample size of 96 patients with early PD-MCI who did not have a drug adjustment plan in the next 3 months they were divided into treatment group (N = 48) and control group (N = 48) according to the ratio of 1:1 a total of 3 times a week for 12 weeks of acupuncture treatment. The clinical efficacy was evaluated before treatment 12 weeks after treatment 24 weeks after treatment (3-month follow-up after treatment) and 48 weeks after treatment (9-month follow-up after treatment) objective to objectively evaluate the efficacy and safety of acupuncture on mild cognitive impairment (MCI) in patients with early PD and to observe whether it can delay the progression of Pd so as to establish a generalizable acupuncture treatment scheme for PD-mci promoting acupuncture as an important treatment for PD-MCI.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

无

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form CRF

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above