HealthyNCT02517060
Neural Mechanisms of Tactile Priming on Social Perceptions - Pilot Study
An observational study of Healthy, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 17 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult male and female subjects
Who may be able to join
- male or female healthy participants
- age 18 - 40 years
Who cannot join
- cardiac pacemaker
- metallic implants
- ferromagnetic parts in / at the body
- tatoos
- vessel surgery
- tinnitus
Show all 9Show fewer
- epilepsia
- claustrophobia
- pregnancy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Psychiatry und Psychotherapy, CCM, Charité - University Medicine Berlin
Berlin, State of Berlin, 10117
Medical School Berlin
Berlin, State of Berlin, 12247
Department of Anesthesiology and Intensvie Care Medicine CVK/CCM, Charité - University Medicine Berlin
Berlin, State of Berlin, 13353
About this study
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.
Read the detailed description
Brain responses of healthy participants were recorded with functional magnetic resonance imaging (fMRI). While being scanned participants were asked to recommend punishments similar to judges or juries for perpetrators across different scenarios. In addition, participants were primed before reading the scenario by using different materials. Based on recent theories about "embodied cognition" and extralegal factors investigators hypothesize that those primes may influence the harshness of punishments recommended by the participants. If those processes engage sensorimotor cortices, the results would strongly support theories of embodied cognition.
The results would help the investigators to understand the neural correlates of priming processes. These unconscious complex processes of perception may be important for hospital patients. Thus, beneficial haptic experiences during the hospital stay may contribute to successful recovery.
- Conditions
- Healthy
- Keywords
- Social perceptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Male or female healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- We examine if tactile priming leads to systematic behavioral changes for evaluation processes. During the fMRI participants were asked to read scenarios and subsequently perform evaluation processes on a likert scale 0 to 5 (0 = mild punishment; 5 = hard punishment) .
Measured: The participants will be followed up for the duration of fMRI-scan, an exspected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Medical School Berlin
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517060
- Sponsor's protocol ID
- SozPrime
- Status last verified
- Aug 2016
- First submitted
- 10 Jul 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Tactile Priming on Social Perceptions - Pilot Study
- ClinicalTrials.gov ID
- NCT02517060
- Acronym / sponsor ID
- SozPrime
- Conditions
- Healthy
- Keywords
- Social perceptions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Medical School Berlin
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain responses of healthy participants were recorded with functional magnetic resonance imaging (fMRI). While being scanned participants were asked to recommend punishments similar to judges or juries for perpetrators across different scenarios. In addition, participants were primed before reading the scenario by using different materials. Based on recent theories about "embodied cognition" and extralegal factors investigators hypothesize that those primes may influence the harshness of punishments recommended by the participants. If those processes engage sensorimotor cortices, the results would strongly support theories of embodied cognition.
The results would help the investigators to understand the neural correlates of priming processes. These unconscious complex processes of perception may be important for hospital patients. Thus, beneficial haptic experiences during the hospital stay may contribute to successful recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | –Male or female healthy participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult male and female subjects
Key inclusion criteria (2 listed)
- male or female healthy participants
- age 18 - 40 years
Key exclusion criteria (9 listed)
- cardiac pacemaker
- metallic implants
- ferromagnetic parts in / at the body
- tatoos
- vessel surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensorimotor brain activation
Time frame: The participantes will be followed up for the duration of fMRI-scan, an exspected average of 1 hour
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.
1 secondary outcome
Systematic changes for evaluation processes
Time frame: The participants will be followed up for the duration of fMRI-scan, an exspected average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Charite University, Berlin, Germany at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensorimotor brain activation (time frame: The participantes will be followed up for the duration of fMRI-scan, an exspected average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.