Evaluating the effectiveness of acupuncture for traumatic brain injury and stroke

ISRCTN	ISRCTN17494271
DOI	https://doi.org/10.1186/ISRCTN17494271
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	EJTCM-D-21-00361
Sponsor	Hualien Tzu Chi Hospital
Funder	Buddhist Tzu Chi Medical Foundation

Submission date: 27/07/2021
Registration date: 30/07/2021
Last edited: 30/07/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
A traumatic brain injury (TBI) is an injury that affects how the brain works. A stroke occurs when the blood supply to part of your brain is interrupted or reduced. TBI and stroke are major causes of death and disability worldwide. Acupuncture has been used as a supplemental treatment for patients with TBI and stroke. The aim of this study is to evaluate the effects of acupuncture treatment for patients with TBI and stroke.

Who can participate?
Patients with TBI or stroke

What does the study involve?
Participants are invited for radial pressure wave measurement before and 20 minutes after acupuncture treatment and after 3 weeks of treatment to observe the effect of the acupuncture treatment.

What are the possible benefits and risks of participating?
Patients may benefit from evaluating the progress of treatment in the future. The radial pulse measuring device is non-invasive with no additional risk.

Where is the study run from?
Hualien Tzu Chi Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
January 2020 to December 2020

Who is funding the study?
Hualien Tzu Chi Hospital (Taiwan)

Who is the main contact?
Dr Jhong-Kuei Chen (Public)
samtati@gmail.com

Contact information

Mr Jhongkuei Chen
Public

No. 707, Sec 3
Zhongyang Road
Hualien
Hualien
970
Taiwan

Phone	+886 (0)3 8561825
Email	hlmweb@tzuchi.com.tw

Study information

Primary study design	Observational
Study design	Observational case series
Secondary study design	Case series
Study type	Participant information sheet
Scientific title	Using radial pulse wave as hemodynamic measurements to quantify the effects of acupuncture therapy for patients with traumatic brain injury and ischemia stroke
Study acronym	RPATTBI
Study objectives	Harmonic indicators may become risk indicators for traumatic brain injury (TBI) patients.
Ethics approval(s)	Approved 01/01/2020, Institutional Review Board of Hualien Tzu Chi Hospital (707, Sec. 3, Chung-Yang Rd., Hualien, 97002, Taiwan, R.O.C.; +886 (0)3 38561825 Ext. 12124; no email provided), ref: IRB108-200-B
Health condition(s) or problem(s) studied	Risk factors in traumatic brain injury patients
Intervention	All subjects undergo radial pressure wave measurement. Spectrum analysis of radial pressure wave is calculated and transformed into Fourier series coefficients Cn and Pn. The clinical research method is divided into two stages, which are the initial measurement and the subsequent follow-up measurement. Each stage will involve two TD01C measurements. The obtained harmonic index will be analyzed by linear regression, chi-square test, etc, to assess whether stroke, traumatic brain injury status and harmonic index are related, and whether these harmonic indicators can assist physicians in monitoring stroke and traumatic brain injury. The process provides a physician's clinical warning function.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Radial pulse spectrum measured using micro-pressure transducer before and 20 minutes after acupuncture treatments 2. Clinical severity measured using Glasgow Coma Scale before and 20 minutes after acupuncture treatments
Key secondary outcome measure(s)	1. Radial pulse spectrum measured using micro-pressure transducer after 3 weeks of treatment 2. Clinical severity measured using Glasgow Coma Scale after 3 weeks of treatment
Completion date	31/12/2020

Eligibility

Participant type(s)	Patient
Age group	All
Sex	All
Target sample size at registration	50
Total final enrolment	20
Key inclusion criteria	1. New stroke (in the last half-year) and traumatic brain injury patients in Hualien Tzu Chi Hospital 2. Any age or gender
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/05/2020
Date of final enrolment	31/12/2020

Locations

Countries of recruitment

Taiwan

Study participating centre

Hualien Tzu Chi Hospital

No. 707, Sec 3
Zhongyang Road
Hualien
970
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/07/2021: Trial's existence confirmed by the institutional review board of Hualien Tzu Chi Hospital.