Acupuncture-induced changes on brain excitability for stroke patients with motor dysfunction
| ISRCTN | ISRCTN13358253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13358253 |
| Secondary identifying numbers | ZYLX201412 |
- Submission date
- 04/09/2016
- Registration date
- 18/10/2016
- Last edited
- 18/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off. Around 80% of strokes are ischemic strokes, in which the arteries that supply the brain with oxygen become narrowed or blocked, causing severely reduced blood flow (ischemia). This can lead to serious complications, depending on which part of the brain is deprived of oxygen and for how long. One of the most common long-term complications from stroke is weakness on one side of the body (hemiparesis). Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needels are placed into the body at specific points. Studies have shown that it can lead to an improvement in hemiparesis following stroke, however the exact mechanism for this is not known, in particular, whether it affects the movement centre of the brain. The aim of this study is to find out whether acupuncture is able to improve hemiparesis following stroke by affecting the movement centre of the brain.
Who can participate?
Adults who have had a stroke and are experiencing weakness in one hand.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive 40 acupuncture sessions over a period of 12 weeks as well as standard care. Those in second group undergo conventional physical therapy for stroke rehabilitation, involving exercises designed to help recover movement. At the start of the study and then after three months, participants in both groups have a brain scan to find out if the therapy they have had has led to changes in the movement centre of the brain. At the same time, participant’s hand function is assessed to find out if it has improved.
What are the possible benefits and risks of participating?
Participants may benefit from recovering movement lost following their stroke. The risks of receiving acupuncture or rehabilitation treatment described in this study are small. In few cases, acupuncture may cause discomfort or pain at the sites during needle insertion, and nausea or feeling faint after insertion. Rehabilitation may lead to muscle sprain, bruising or tiredness.
Where is the study run from?
1. Beijing Hospital of Traditional Chinese Medicine (China)
2. China Rehabilitation Research Center (China)
When is the study starting and how long is it expected to run for?
December 2015 to June 2017
Who is funding the study?
Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding (China)
Who is the main contact?
Professor Linpeng Wang
wlp5558@sina.com
Contact information
Scientific
Meishuguanhoujie No. 23
Dongcheng Province
Beijing
100010
China
 ORCID ID |
0000-0002-0775-9939 |
|---|
Study information
| Study design | Two-arm single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Characterizing the neurophysiological mechanisms of acupuncture on motor functional recovery after stroke: a randomized controlled study |
| Study hypothesis | Acupuncture exerts its positive effects on post-stroke motor behavior by influencing cortical plasticity. |
| Ethics approval(s) | Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine, 24/03/2016, ref: 2016BL-018-01 |
| Condition | Motor dysfunction after stroke |
| Intervention | Participants who meet the eligibility criteria will be randomly assigned to one of the two groups in a 1:1 ratio. Randomization will be conducted using computer-generated random numbers placed in sequentially numbered, sealed opaque envelopes and kept by a clinician with no contact to study participants. Both acupuncture and rehabilitation groups will receive a total of 40 treatment sessions in 12 weeks. Participants in both groups will receive standard medical care for stroke throughout the trial, which will be conducted in accordance with the China Guideline for the Diagnosis and Treatment of Acute Ischemic Stroke (2010). The acupuncture group will additionally receive manual acupuncture for 12 weeks. Twelve acupoints will be used for all the patients. Each session will last for 40 minutes. For the control group, patients will undergo conventional physical therapy. The structure of the intervention will be customized to each individual’s functional level. Each session will have a duration of 40 minutes. Participants in both groups are followed up at the end of the intervention period (12 weeks), at which time they will undergo transcranial magnetic stimulation and motor function testing. |
| Intervention type | Supplement |
| Primary outcome measure | Excitability of primary motor cortex measured by recruitment curve of Motor Evoked Potential by transcranial magnetic stimulation at baseline and 3 months |
| Secondary outcome measures | 1. Motor function of hand and arm are measured using the Action Research Arm Test and the upper-extremity portion of the Fugl-Meyer motor assessment at baseline and 3 months 2. General motor disability is measured using the modified Rankin scale at baseline and 3 months 3. Neurological deficit is measured using National Institutes of Health Stroke Scale assessment at baseline and 3 months 4. The muscle strength level is measured using the UK Medical Research Council standard at baseline and 3 months |
| Overall study start date | 01/12/2015 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. First-ever mono-hemispheric ischemic stroke 2. Within 14 days after stroke onset 3. Hand weakness with MRC level of 1 to 4 4. Aged between 18 and 80 |
| Participant exclusion criteria | 1. Participation in other medical studies at present or during the previous 3 months 2. Pre-existing conditions of body dysfunction before stroke attack 3. Pregnancy 4. Cognitive or communication impairment or pre-existing conditions precluding informed consent or compliance with study assessments |
| Recruitment start date | 01/09/2016 |
| Recruitment end date | 31/12/2016 |
Locations
Countries of recruitment
- China
Study participating centres
Dongcheng Province
Beijing
100010
China
Fengtai province
Beijing
100068
China
Sponsor information
Hospital/treatment centre
Meishuguanhoujie no. 23
Dongcheng District
Beijing
100010
China
"ROR" |
https://ror.org/057vq6e26 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study is about to be presented in an original study paper and published in the second half of 2017. |
| IPD sharing plan |
