XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453906
• Other study ID #: XNKQ-15
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: July 26, 2016
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• XNKQ
stimulation at 5 acupuncture points according to XNKQ acupuncture
• Control 1
no stimulation at 5 acupuncture points according to XNKQ acupuncture
• Control 2
stimulation at 5 control points
• Control 3
no stimulation at 5 control points

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Claudia M. Witt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No