Effectiveness of YNSA Acupuncture on Brain Networks

Acupuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795024
• Other study ID #: YNSA-EFF
• Status: Completed
• Start date: January 15, 2020
• Est. completion date: August 24, 2020

Study information

• Verified date: July 2021
• Source: BDH-Klinik Hessisch Oldendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adults aged 18 to 65

Exclusion Criteria:

• mental disorders (dementia, depression)

• MRI contraindications

• claustrophobia

• weight > 120 kg

Related Conditions & MeSH terms

• Acupuncture

Locations

Country	Name	City	State
Germany	BDH-Clinic Hessisch Oldendorf	Hessisch Oldendorf

Sponsors (1)

Lead Sponsor	Collaborator
BDH-Klinik Hessisch Oldendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schockert T, Schnitker R, Boroojerdi B, Smith IQ, Yamamoto T, Vietzke K, Kastrau F. Cortical activation by Yamamoto new scalp acupuncture in the treatment of patients with a stroke: a sham-controlled study using functional MRI. Acupunct Med. 2010 Dec;28(4):212-4. doi: 10.1136/aim.2010.002683. Epub 2010 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changed functional connectivity	Functional connectivity is measured using resting-state fMRI.	35 minutes