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Completed

NCT Number: NCT02453906

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

XNKQ

Other

stimulation at 5 acupuncture points according to XNKQ acupuncture

Control 1

Other

no stimulation at 5 acupuncture points according to XNKQ acupuncture

Control 2

Other

stimulation at 5 control points

Control 3

Other

no stimulation at 5 control points

Primary outcomes

  1. 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.

    Time frame: 60 minutes

  2. 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

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Claudia M. Witt

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 27, 2015
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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