XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI
Cerebral Response of Healthy Subjects to a Somatosensory Stimulation With XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI
1 other identifier
interventional
29
1 country
1
Brief Summary
The investigators will use EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal responses in 28 healthy subjects to different somatosensory stimulations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started May 2015
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJuly 27, 2016
July 1, 2016
4 months
April 29, 2015
July 26, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in brain background rhythms (mu-alpha and beta activity) [assessed using EEG and MRI] after one intervention (baseline vs. post stimulation) in comparison between the four different interventions.
60 minutes
Changes in resting state functional connectivity [assessed using EEG and MRI] after one intervention (baseline vs. post-stimulation) in comparison between the four different interventions
60 minutes
Study Arms (1)
healthy subjects
EXPERIMENTALthey receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy subjects (18 to 40 years of age) health status confirmed by a comprehensive neurological examination
- Right-handed (evaluated by "the Edinburgh inventory")
- Informed consent
- No acupuncture treatment in the last 12 months
- No medical knowledge about acupuncture
You may not qualify if:
- History of neurological and/or psychiatric diseases
- History of brain injury
- Cognitive handicap and severe speech disorder
- alcohol or drug abuse
- History of neurosurgical intervention
- Chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
- Usage of acute medication
- Pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
- Any contraindication for acupuncture (e.g., anti-coagulation therapy)
- Participation in another interventional trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Claudia M. Wittlead
Study Sites (1)
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Related Publications (1)
Nierhaus T, Chang Y, Liu B, Shi X, Yi M, Witt CM, Pach D. Somatosensory Stimulation With XNKQ Acupuncture Modulates Functional Connectivity of Motor Areas. Front Neurosci. 2019 Mar 11;13:147. doi: 10.3389/fnins.2019.00147. eCollection 2019.
PMID: 30914909DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia M. Witt, MD
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 27, 2015
Study Start
May 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
July 27, 2016
Record last verified: 2016-07