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Completed

NCT Number: NCT04795024

Effectiveness of YNSA Acupuncture on 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, 31840, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults aged 18 to 65

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Changed functional connectivity

    Time frame: 35 minutes

    Functional connectivity is measured using resting-state fMRI.

Sponsors and collaborators

Lead sponsor

BDH-Klinik Hessisch Oldendorf

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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