- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05101161
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oliver Bichsel, MD, MSc ETH
- Phone Number: +41 44 510 72 34
- Email: oliver.bichsel@hest.ethz.ch
Study Locations
-
-
Zurich
-
Zürich, Zurich, Switzerland, 8092
- Recruiting
- ETH Zurich
-
Contact:
- Oliver Bichsel, MD, MSc ETH
- Phone Number: +41 44 510 72 34
- Email: oliver.bichsel@hest.ethz.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
patients undergoing clinically indicated implantation of a Percept™ PC neurostimulator, age ≥ 18 years as well as planned hospitalisation of ≥ 3 days after operation
Exclusion Criteria:
minimal prognosticated survival of less than 1 year, reduced state of consciousness (i. e. Glasgow Coma Scale < 15), inability to communicate (in terms of hearing, seeing, speaking and understanding), other significant concomitant diseases (e. g. cardiovascular disease, infectious disease, isolation), inability to follow procedures, insufficient knowledge of project language, inability to give consent and unlikeliness to follow protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bidirectional Neurofeedback
|
Modulating brain oscillations based on visual neurofeedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of endogenous neuromodulation (difference in oscillatory power)
Time Frame: 60 Minutes
|
The investigators will assess the amount of endogenous modulation of the neurofeedback parameter as compared to a baseline state ('rest') as well as in a bidirectional neurofeedback design (upregulation vs. downregulation).
Local field potentials are measured (LFP-recording; physiological parameter; for Parkinson patients the beta-frequencies will be assessed during the study period) using already implanted deep brain stimulation electrodes (Medtronic DBS electrodes) and used to compute the neurofeedback parameter.
The amount of endogenous neuromodulation is determined as the difference of power of neuronal oscillations between two conditions [unit of measure: %-difference in power of deep brain neuronal oscillations].
|
60 Minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
performance in motor activity tasks
Time Frame: 60 min
|
The investigators will assess the 'performance in motor activity tasks' (= name of the measurement) using the measurement tools of wearable inertial measurement units (IMUs) and motion detectors.
The following units of measure (physiological parameters) could be extracted from the recorded data: speed of movement, smoothness of movement, extent of movement.
|
60 min
|
transfer of neurofeedback-learnt strategies
Time Frame: 60 min
|
The investigators will assess the amount of endogenous modulation of the neurofeedback parameter as compared to a baseline state ('rest') as well as in a bidirectional neurofeedback design (upregulation vs. downregulation) in the ABSENCE of active neurofeedback.
Local field potentials are measured (LFP-recording; physiological parameter; for Parkinson patients the beta-frequencies will be assessed during the study period) using already implanted deep brain stimulation electrodes (Medtronic DBS electrodes) and used to compute the neurofeedback parameter.
The amount of endogenous neuromodulation is determined as the difference of power of neuronal oscillations between two conditions [unit of measure: %-difference in power of deep brain neuronal oscillations].
|
60 min
|
agency as measured on a visual scale (1-10)
Time Frame: 60 min
|
the subjectively perceived ability to control deep brain oscillatory activity.
Patients will be asked to indicate the perceived ability (agency) to control the neurofeedback parameter on a visual scale from 0 (no control) to 10 (perfect control).
|
60 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oliver Bichsel, MD, MSc ETH, ETH Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NF-DBS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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