NCT02453906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

April 29, 2015

Last Update Submit

July 26, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

healthy subjects

EXPERIMENTAL

they receive XNKQ acupuncture, as well as control 1, control 2, and control 3 in a randomized order.

Other: XNKQOther: Control 1Other: Control 2Other: Control 3

Interventions

XNKQOTHER

stimulation at 5 acupuncture points according to XNKQ acupuncture

healthy subjects

no stimulation at 5 acupuncture points according to XNKQ acupuncture

healthy subjects

stimulation at 5 control points

healthy subjects

no stimulation at 5 control points

healthy subjects

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Participation in another interventional trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Location

Related Publications (1)

  • Nierhaus T, Chang Y, Liu B, Shi X, Yi M, Witt CM, Pach D. Somatosensory Stimulation With XNKQ Acupuncture Modulates Functional Connectivity of Motor Areas. Front Neurosci. 2019 Mar 11;13:147. doi: 10.3389/fnins.2019.00147. eCollection 2019.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Claudia M. Witt, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07

Locations