Clinical trial NCT04795024: Effectiveness of YNSA Acupuncture on Brain Networks
Official title: Effectiveness of Yamamoto's New Skull Acupuncture (YNSA) on Resting State Brain Networks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acupuncture
Keywords: Resting-state fMRI
Lead sponsor: BDH-Klinik Hessisch Oldendorf
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers of both sexes aged 18-65 years

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.

Eligibility criteria: Inclusion Criteria:

* adults aged 18 to 65

Exclusion Criteria:

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

Primary outcomes:
measure: Changed functional connectivity
timeFrame: 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hessisch Oldendorf
country: Germany
facility: BDH-Clinic Hessisch Oldendorf
Study officials:
affiliation: BDH-Clinic Hessisch Oldendorf
name: Jens D Rollnik, MD
role: STUDY_DIRECTOR
References:
citation: 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.