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XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

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ClinicalTrials.gov Identifier: NCT02453906
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Other: XNKQ Other: Control 1 Other: Control 2 Other: Control 3 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Cerebral Response of Healthy Subjects to a Somatosensory Stimulation With XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI
Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453906


Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Sponsors and Collaborators
Claudia M. Witt
Investigators
Principal Investigator: Claudia M. Witt, MD Charite University, Berlin, Germany
More Information
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Responsible Party: Claudia M. Witt, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02453906     History of Changes
Other Study ID Numbers: XNKQ-15
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016