NCT04795024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

March 9, 2021

Last Update Submit

July 20, 2021

Conditions

Acupuncture

Keywords

Resting-state fMRI

Outcome Measures

Primary Outcomes (1)

  • Changed functional connectivity

    Functional connectivity is measured using resting-state fMRI.

    35 minutes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers of both sexes aged 18-65 years

You may qualify if:

  • adults aged 18 to 65

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, 31840, Germany

Location

Related 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. No abstract available.

    PMID: 20923941BACKGROUND

Study Officials

  • Jens D Rollnik, MD

    BDH-Clinic Hessisch Oldendorf

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

January 15, 2020

Primary Completion

August 24, 2020

Study Completion

August 24, 2020

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

DE(1)