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Clinical Trials/NCT02453906
NCT02453906
Completed
N/A

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

Claudia M. Witt1 site in 1 country29 target enrollmentMay 2015
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Claudia M. Witt
Enrollment
29
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
September 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Claudia M. Witt
Responsible Party
Sponsor Investigator
Principal Investigator

Claudia M. Witt

Professor

Charite University, Berlin, Germany

Eligibility 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.)

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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