XNKQ Acupuncture Compared to Control Interventions Measured With EEG and fMRI

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: XNKQ; Other: Control 1; Other: Control 2; Other: Control 3

• Registration Number: NCT02453906
• Lead Sponsor: Claudia M. Witt

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.

Study Timeline

• Study First Submitted: 2015-04-29
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
healthy subjects	Control 1	they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.
healthy subjects	XNKQ	they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.
healthy subjects	Control 3	they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.
healthy subjects	Control 2	they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany