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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: XNKQ; Other: Control 1; Other: Control 2; Other: Control 3

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Claudia M. Witt
• Investigators: Principal Investigator: Claudia M. Witt, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: XNKQ-15