Condition category
Nervous System Diseases
Date applied
24/01/2017
Date assigned
25/01/2017
Last edited
25/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Linpeng Wang

ORCID ID

http://orcid.org/0000-0002-0775-9939

Contact details

Beijing Hospital of Traditional Chinese Medicine
Meishuguanhoujie No. 23
Dongcheng Province
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZYLX201412

Study information

Scientific title

Neuroplasticity changes on human motor cortex induced by acupuncture therapy for health subjects: a preliminary study

Acronym

Study hypothesis

Bilateral excitability of primary motor cortex and interhemispheric interaction could be modulated by acupuncture intervention on healthy subject.

Ethics approval

Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine, 24/03/2016, ref: 2016BL-018-001

Study design

Interventional single-centre randomised cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2015

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Without neurological, psychiatric or other medical problems
2. Right-handed
3. Aged 18-65 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Ten

Participant exclusion criteria

Reported contra-indication to transcranial magnetic stimulation.

Recruitment start date

02/05/2016

Recruitment end date

24/07/2016

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine
Meishuguanhoujie No. 23 Dongcheng Province
Beijing
100010
China

Sponsor information

Organisation

Beijing Hospital of Traditional Chinese Medicine

Sponsor details

Meishuguanhoujie no. 23
Dongcheng District
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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)

Intention to publish date

01/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes