XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

Study Overview
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Brief Summary
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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.

Detailed Description
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To develop a better understanding of the cerebral response to a complex somatosensory intervention with XNKQ acupuncture and to build a foundation for future studies with stroke patients our study aims to evaluate changes of brain activity and brain structure in healthy subjects after XNKQ acupuncture in comparison to three control interventions. We will use EEG, structural MRI, and resting-state functional connectivity MRI to assess neuronal responses in 28 healthy subjects to a) strong manual needle-stimulation of the acupuncture points DU26, PC6 and SP6 (XNKQ acupuncture), b) insertion of needles on the acupuncture points DU26, PC6 and SP6 without stimulation (control 1), c) strong manual needle stimulation of three non-acupuncture points (control 2), and d) insertion of needles on three non-acupuncture points without stimulation (control 3). With this, our study aims to create results which inform future studies in patients and might be helpful for the rehabilitation of deficits after stroke.

Official Title
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Cerebral Response of Healthy Subjects to a Somatosensory Stimulation With XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

Conditions
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Stroke

Intervention / Treatment
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* Other: XNKQ
* Other: Control 1
* Other: Control 2
* Other: Control 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) Any exclusion criteria for MRI scanning (metal implants (e.g. pacemaker), claustrophobia, etc.) Participation in another interventional trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy subjects<br>they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order. | Other: XNKQ<br>* stimulation at 5 acupuncture points according to XNKQ acupuncture<br>Other: Control 1<br>* no stimulation at 5 acupuncture points according to XNKQ acupuncture<br>Other: Control 2<br>* stimulation at 5 control points<br>Other: Control 3<br>* no stimulation at 5 control points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |