XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

NCT ID: NCT02453906

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-09-30

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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healthy subjects

they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.

Group Type EXPERIMENTAL

XNKQ

Intervention Type OTHER

stimulation at 5 acupuncture points according to XNKQ acupuncture

Control 1

Intervention Type OTHER

no stimulation at 5 acupuncture points according to XNKQ acupuncture

Control 2

Intervention Type OTHER

stimulation at 5 control points

Control 3

Intervention Type OTHER

no stimulation at 5 control points

Interventions

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XNKQ

stimulation at 5 acupuncture points according to XNKQ acupuncture

Intervention Type OTHER

Control 1

no stimulation at 5 acupuncture points according to XNKQ acupuncture

Intervention Type OTHER

Control 2

stimulation at 5 control points

Intervention Type OTHER

Control 3

no stimulation at 5 control points

Intervention Type OTHER

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)
* Participation in another interventional trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Claudia M. Witt

OTHER

Sponsor Role lead

Responsible Party

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Claudia M. Witt

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Claudia M. Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30914909 (View on PubMed)

Other Identifiers

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XNKQ-15

Identifier Type: -

Identifier Source: org_study_id

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