NCT02517060

Brief Summary

The investigators measure brain responses of healthy participants while they perform evaluation tasks inside the fMRI. For each task the participants were primed with tactile stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming, hence confirming embodiment theories.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

July 10, 2015

Last Update Submit

August 9, 2016

Conditions

Keywords

Social perceptions

Outcome Measures

Primary Outcomes (1)

  • Sensorimotor brain activation

    The primary objective of this study is to examine neural correlates for embodied cognitions. We use an fMRI-approach to test if healthy participants are prone to non-conscious tactile priming effects during evaluation processes. Investigators measure the outcome by examining BOLD Response in the sensorimotor cortices (Maximum Peak in Primary somatosensory Cortex, SI). BOLD Responses will be analyzed using the Software SPM 8.

    The participantes will be followed up for the duration of fMRI-scan, an exspected average of 1 hour

Secondary Outcomes (1)

  • Systematic changes for evaluation processes

    The participants will be followed up for the duration of fMRI-scan, an exspected average of 1 hour

Study Arms (1)

Healthy participants

Male or female healthy participants

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy adult male and female subjects

You may qualify if:

  • male or female healthy participants
  • age 18 - 40 years

You may not qualify if:

  • cardiac pacemaker
  • metallic implants
  • ferromagnetic parts in / at the body
  • tatoos
  • vessel surgery
  • tinnitus
  • epilepsia
  • claustrophobia
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Psychiatry und Psychotherapy, CCM, Charité - University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

Location

Medical School Berlin

Berlin, State of Berlin, 12247, Germany

Location

Department of Anesthesiology and Intensvie Care Medicine CVK/CCM, Charité - University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

Location

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Study Record Dates

First Submitted

July 10, 2015

First Posted

August 6, 2015

Study Start

August 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations