Effectiveness of YNSA Acupuncture on Brain Networks

NCT ID: NCT04795024

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2020-08-24

Brief 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.

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.

Conditions

Acupuncture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• adults aged 18 to 65

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BDH-Klinik Hessisch Oldendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens D Rollnik, MD

Role: STUDY_DIRECTOR

BDH-Clinic Hessisch Oldendorf

Locations

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, , Germany

Countries

Germany

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 20923941 (View on PubMed)

Other Identifiers

YNSA-EFF

Identifier Type: -

Identifier Source: org_study_id