Acupuncture-induced changes on brain excitability and interhemispheric interaction for healthy subject
| ISRCTN | ISRCTN13074245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13074245 |
| Secondary identifying numbers | ZYLX201412 |
- Submission date
- 24/01/2017
- Registration date
- 25/01/2017
- Last edited
- 27/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Acupuncture is a form of traditional Chinese medicine, which has been used to treat a range of medical conditions. It has been used as a treatment for the rehabilitation of stroke patients with one-sided weakness (hemiparesis) for decades), and has been shown to help in the recovery of movement (motor recovery). The reason for this is unknown, however some believe that the acupuncture causes new connections in the brain to form in order to use new pathways to avoid the old, affected ones (neuroplasticity). The aim of this study is to use a type of brain scanning to find out whether acupuncture can lead to neuroplastic changes in the brain in healthy adults.
Who can participate?
Ten healthy adult volunteers.
What does the study involve?
Participants are allocated to undergo two treatment periods in a random order, with seven days of no treatment in between. The first treatment period involves 30 minutes of acupuncture. This involves having acupuncture needles applied to acupoints (locations on the body affected by acupuncture) in the left hand, arm and lower leg, which are then moved around to create an aching, tingling sensation. The second treatment involves sitting in a comfortable chair whilst being relaxed and alert for 30 minutes. Before and 10 minutes after each treatment period, participants in both groups have a brain scan to see if the treatment has had any effect on the brain.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for those participating in this study.
Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine (China)
When is the study starting and how long is it to run for?
December 2015 to July 2016
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
Beijing Hospital of Traditional Chinese Medicine
Meishuguanhoujie No. 23
Dongcheng Province
Beijing
100010
China
 ORCID ID |
0000-0002-0775-9939 |
|---|
Study information
| Study design | Interventional single-centre randomised cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Neuroplasticity changes on human motor cortex induced by acupuncture therapy for health subjects: a preliminary study |
| Study objectives | Bilateral excitability of primary motor cortex and interhemispheric interaction could be modulated by acupuncture intervention on healthy subject. |
| Ethics approval(s) | Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine, 24/03/2016, ref: 2016BL-018-001 |
| Health condition(s) or problem(s) studied | Cortical neural plasticity |
| Intervention | Participants are randomised to receive two treatment periods in a random order. Between the treatment periods, there is a 7 day wash-out period where no treatment is received. Intervention period: Participants receive a 30 minute period of acupuncture treatment, in which needles are applied to ten acupoints located on the left forearm, hand and lower leg are applied. The needling methods of “lifting and thrusting” and “rotating” are conducted on each point until the sensation of Deqi (a characteristic sensation of aching and tingling) is reported by the subjects. Then, the needles are kept in situ without further stimulation. Control period: Participants are asked to sit comfortably on an armchair and are instructed to keep relaxed but alert during the control period. No needling stimulation takes place. Transcranial magnetic stimulation measures, including resting motor threshold, amplitudes of motor evoked potential and interhemispheric inhibition are assessed before and 10 minutes after each treatment period. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Amplitudes of motor evoked potential on primary motor cortex are measured using the transcranial magnetic stimulation before and 10 minutes after each treatment period. |
| Secondary outcome measures | 1. Resting motor threshold is measured using transcranial magnetic stimulation before and 10 minutes after each treatment period 2. Interhemispheric inhibition is measured using transcranial magnetic stimulation before and 10 minutes after each treatment period 3. F-wave is measured using electromyography before and 10 minutes after each treatment period |
| Overall study start date | 01/12/2015 |
| Completion date | 31/07/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Without neurological, psychiatric or other medical problems 2. Right-handed 3. Aged 18-65 years |
| Key exclusion criteria | Reported contra-indication to transcranial magnetic stimulation. |
| Date of first enrolment | 02/05/2016 |
| Date of final enrolment | 24/07/2016 |
Locations
Countries of recruitment
- China
Study participating centre
Dongcheng Province
Beijing
100010
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 | 01/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in the journal Neural Plasticity before March 2017. The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Linpeng Wang (wlp5558@sina.com) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | 27/11/2020 | Yes | No |
Editorial Notes
27/11/2020: Publication reference and total final enrolment number.
