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SNCTP000002966 | DRKS00016909 | BASEC2018-01078

Auswirkung kognitiver Zustände auf sensorische Wahrnehmung und Motorik

Data source: BASEC (Imported from 07.05.2021), WHO (Imported from 18.04.2021)
Changed: 04.05.2021
Disease category: Basic research (Anatomy/Physiology)

Brief description of trial (Data source: BASEC)

In diesem Projekt untersuchen wir den Einfluss von sensorischer Wahrnehmung, d.h. Sehen, Hören und Tasten auf die Motorik, d.h. verschiedene Bewegungsabläufe. Spezifisch sind wir interessiert wie verschiedene kognitive Zustände, d.h. Müdigkeit oder Motivation sich auf den Informationsfluss zwischen sensorischer Wahrnehmung und Motorik auswirken. Wir hoffen, dass das Verständnis dieser Hirnprozesse im gesunden Probanden uns neue Möglichkeiten für die zukünftige Behandlung von Kranken (z.Bsp. Schlaganfallpatienten) liefern kann.

Health conditions investigated (Data source: BASEC)

In diesem Projekt werden ausschliesslich gesunde Probanden untersucht.

Health conditions (Data source: WHO)

Basic research in healthy participants # Healthy participants

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

NA

Interventions (Data source: WHO)

Intervention 1: The project involves neurophysiological measurements (e.g. fMRI, EEG and EMG) as well as non-invasive brain stimulation (e.g. TMS, tCS) during behavioural tests (e.g. sensorimotor and cognitive tasks).

Criteria for participation in trial (Data source: BASEC)

Es können alle Personen teilnehmen, die zwischen 18 und 65 Jahre alt und in guter gesundheitlicher Verfassung sind. Übrige Bedingungen für die Studienteilnahme beim Gebrauch von MRT oder TMS sind:

• Erfüllen der Kriterien des MRT Fragebogens
• Erfüllen der Kriterien des TMS Fragebogens

Exclusion criteria (Data source: BASEC)

Keine Schwangerschaft: Ein Schwangerschaftstest für Frauen im fruchtbaren Alter ist vor der MRT Untersuchung Pflicht
• Keine neurologischen, psychiatrischen oder muskulären Krankheiten
• Keine Einnahme von Psychopharmaka
• Keine metallischen Gegenstände am und im Körper
• Keine Arbeitstätigkeit in der Metallindustrie, da sie dann bspw. Metallsplitter im Auge haben könnten.
• Keine mechanischen Implantate

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria: Healthy participants
Age 18 – 65 years
Normal physical and mental health
Normal or corrected to normal vision
Exclusion criteria: Known history of neurological, musculoskeletal or neuromuscular disorders.
Pregnancy.
Participants with metal implants in their body including pacemakers, or electronically/magnetically/mechanically activated implants.

Further information on the trial in WHO primary registry

http://www.drks.de/DRKS00016909

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00016909

Further information on trial

Date trial registered

17.12.2019

Incorporation of the first participant

01.09.2018

Recruitment status

Recruiting

Academic title (Data source: WHO)

Investigation of the effects of cognitive states on sensory gating and motor output

Type of trial (Data source: WHO)

observational

Design of the trial (Data source: WHO)

Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Basic research/physiological study

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Electrophysiological markers of brain activity as measured with EEG (Electroencephalography).
BOLD (blood oxygenation level dependent) signal changes as measured with fMRI (Functional magnetic resonance imaging).
Muscle activity as measured with EMG (Electromyography).
Performance on behavioural tasks (accuracy, reaction time, and others).
Eye and motion tracking measures. The planned end date of the study is 1. September 2024.

Secundary end point (Data source: WHO)

Not applicable

Contact information (Data source: WHO)

NCM-Lab, ETH Zürich

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

Yes
Anonymised measurement data can only be made available to other research groups if participants sign the corresponding separate written consent form for further data use. The written consent allows both the sharing of anonymized data upon request as well as upload of the data to scientific databases. This agreement does not expire.

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Nicole Wenderoth
+41 44 633 29 38
nicole.wenderoth@hest.ethz.ch

Contact for general information (Data source: WHO)

Nicole
Wenderoth
Auguste-Piccard-Hof 1
NCM-Lab, ETH Zürich
+41 44 635 61 55
nicole.wenderoth@hest.ethz.ch

Contact for scientific information (Data source: WHO)

Nicole
Wenderoth
August-Piccard-Hof 1
NCM-Lab, ETH Zürich
+41 44 635 61 55
nicole.wenderoth@hest.ethz.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

NCM-Lab, ETH Zürich

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

23.08.2018

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-01078

Secondary ID (Data source: WHO)

BASEC-Nr. 2018-01078