Effectiveness of YNSA Acupuncture on Brain Networks

July 20, 2021 updated by: BDH-Klinik Hessisch Oldendorf

Effectiveness of Yamamoto's New Skull Acupuncture (YNSA) on Resting State Brain Networks

This study investigates the effects of a new form of acupuncture (Yamamoto's New Skull Acupuncture [YNSA]) on resting-state brain networks. Therefore, two resting-state fMRI scans are measured (one without and one with acupuncture needles) in healthy adults. It is expected that acupuncture is associated with changes in functional connectivity within different brain networks.

Study Overview

Status

Completed

Conditions

Detailed Description

Although acupuncture has been used in China and Japan for over 2000 years, it has only become increasingly important in Western medicine in the last few decades. A special form of acupuncture is "Yamamoto's New Skull Acupuncture" (YNSA), which was developed by Toshikatsu Yamamoto. Here, the needling is limited to the skull.

Acupuncture is a safe and almost painless procedure that is usually well tolerated. One indication might be the therapy of neurological diseases. Schockert and colleagues examined the effectiveness of YNSA in a placebo-controlled study. To investigate the effectiveness of cranial acupuncture, three fMRI sequences were performed: 1) without acupuncture, 2) sham acupuncture (acupressure without needling) and 3) YNSA acupuncture. The subjects (17 stroke patients with right hemisphere lesions and 19 healthy controls) were instructed to alternately make a fist (3s) and close it again (2s). There were a total of five blocks, each with a duration of 120s. Compared to sham acupuncture, cortical activations in motor, premotor and supplementary motor areas were observed during YNSA acupuncture.

In contrast to Schockert and colleagues, the planned study uses resting-state fMRI to determine whether YNSA acupuncture is associated with changes of functional connectivity within different resting-state networks.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hessisch Oldendorf, Germany, 31840
        • BDH-Clinic Hessisch Oldendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy volunteers of both sexes aged 18-65 years

Description

Inclusion Criteria:

  • adults aged 18 to 65

Exclusion Criteria:

  • mental disorders (dementia, depression)
  • MRI contraindications
  • claustrophobia
  • weight > 120 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changed functional connectivity
Time Frame: 35 minutes
Functional connectivity is measured using resting-state fMRI.
35 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BDH-Klinik Hessisch Oldendorf

Investigators

  • Study Director: Jens D Rollnik, MD, BDH-Clinic Hessisch Oldendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

August 24, 2020

Study Completion (Actual)

August 24, 2020

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YNSA-EFF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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