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Parkinson DiseaseNCT05101161

Neurofeedback Using Implanted Deep Brain Stimulation Electrodes

A study testing Neurofeedback in people with Parkinson Disease and Epilepsy, run by ETH Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Deep brain stimulation (DBS) has become a gold-standard symptomatic treatment option for Parkinson's disease (PD) and is also explored for a variety of other neurological disorders. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Epilepsy, Essential Tremor
What is being tested?
Neurofeedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
23 Sep 2021to 23 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients undergoing clinically indicated implantation of a Percept™ PC neurostimulator, age ≥ 18 years as well as planned hospitalisation of ≥ 3 days after operation

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oliver Bichsel, MD, MSc ETH contact

+41 44 510 72 34

oliver.bichsel@hest.ethz.ch

Switzerland1 site, 1 recruiting
  • ETH Zurich

    Zurich, Canton of Zurich, 8092

    Oliver Bichsel, MD, MSc ETH, +41 44 510 72 34, oliver.bichsel@hest.ethz.ch

    Recruiting

Other trials in Switzerland

About this study

Deep brain stimulation (DBS) has become a gold-standard symptomatic treatment option for Parkinson's disease (PD) and is also explored for a variety of other neurological disorders. The implantation of electrodes into deep brain areas has not only enabled the application of electrical stimuli, but has also provided researchers and clinicians with an unprecedented window to investigate aberrant neuronal activity right at the core of pathological brain circuits. Local field potentials (LFP) have already been readily investigated through externalised DBS electrode wires prior to internalisation and connection to an implantable neurostimulator. In the case of PD, motor symptoms have been evidenced to correlate with exaggerated beta oscillatory activity (13-35 Hz) in the LFP recorded from the subthalamic nucleus (STN). Firstly, beta activity recorded in the STN at rest in patients withdrawn from their medication has been correlated with the Unified Parkinson's Disease Rating Scale (UPDRS) across patients. Secondly, a reduction of signal power in the beta-band was correlated with clinical improvements of motor symptoms. Thirdly, the two main therapeutic strategies, the administration of L-Dopa, and high-frequency DBS both lead to a suppression of beta-synchronicity in the STN. Furthermore, beta-oscillations show fast and movement-dependent modulation over time and can serve as a biomarker and feedback signal to control the delivery of DBS. The investigators recently implemented deep brain electrical neurofeedback to provide real-time visual neurofeedback of pathological STN oscillations through externalised DBS electrodes and showed that PD patients were able to volitionally control and reduce subthalamic activity within a single 1 hour session. Moreover, neurofeedback-learnt strategies accelerated movements and could be retained in the short- and mid-term. Only recently, a newly developed neurostimulator, the Percept™ PC (Medtronic Neurological Division, Minneapolis, MN, USA), has been clinically approved, which can not only apply electrical impulses, but also enable the measurement and transmission of brain activity. This neurostimulator is now the first choice for implantations at the University Hospital Zurich and is used for a variety of neurological disorders. The investigators' goal is to investigate whether neurofeedback through a fully implanted deep brain stimulation device is possible and can lead to a better control of pathological oscillations as well as symptom mitigation. Having shown that endogenous control over deep brain oscillations is possible, the investigators will also test this novel therapeutic approach for pathologies other than PD that are also treated with DBS. Neurofeedback using implanted DBS electrodes will have the advantage of enabling longer and multiple-day training sessions, which the investigators hypothesise to have a larger impact on control over pathological deep brain oscillations and neurological symptoms, as such a fully implanted neurofeedback system no longer requires the externalisation of DBS wires and is as such no longer limited to the first two days after electrode implantation. All in all, the investigators will not exceed a total streaming time of 7 hours per patients (7 d of battery time), which the investigators deem justifiable with respect to a battery life of > 5 years. This proposed research is highly significant as it will help our understanding of various neurological diseases that are highly prevalent in society (PD being, for instance, the second most common neurodegenerative disorder after Alzheimer's disease) and might culminate in novel, endogenous treatment strategies. The overall risk for patients is minimal to non-existent, as stimulation parameters are unaffected and the intended changes in brain activity are self-induced while DBS stimulation is off.

Being tested
Neurofeedback
Medical subject headings
Parkinson Disease, Epilepsy, Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurofeedbackBehavioural

    Modulating brain oscillations based on visual neurofeedback

Study groups in NCT05101161
Study groupRoleWhat they receive
Bidirectional NeurofeedbackExperimentalNot described
Receives: Behavioral: Neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of endogenous neuromodulation (difference in oscillatory power)

    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].

    Measured: 60 Minutes

Secondary outcomes (3)
  1. performance in motor activity tasks

    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.

    Measured: 60 min

  2. transfer of neurofeedback-learnt strategies

    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].

    Measured: 60 min

  3. agency as measured on a visual scale (1-10)

    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).

    Measured: 60 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start23 Sep 2021
  3. Primary completion23 Sep 2028 (estimated)
  4. Study completion23 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101161
Sponsor's protocol ID
NF-DBS
Status last verified
Sep 2026
First submitted
23 Sep 2021
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Neurofeedback in people with Parkinson Disease and Epilepsy, run by ETH Zurich at 1 site in Switzerland.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oliver Bichsel, MD, MSc ETH (+41 44 510 72 34, oliver.bichsel@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of endogenous neuromodulation (difference in oscillatory power) (time frame: 60 Minutes). 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 14 Sep 2026.

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