Parkinson DiseaseNCT05184270
Integration of Auditory, and Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease
A study testing Acoustic stimulation in people with Parkinson Disease, run by Christian Baumann at 1 site in Switzerland.
Trial summary
The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Acoustic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Nov 2021to 7 Mar 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Diagnosis of PD along with international criteria with mild to moderate disease severity (Hoehn-Yahr (HY) stages ll-lll), selected for receiving STN-DBS therapy with the neurostimulator PERCEPT™
- Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
- Age above 18 years
- Negative pregnancy test during screening in female patients of childbearing potential (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year)
Who cannot join
- Failure to give informed consent
- Known presence of neurologic (other than PD), psychiatric, or systemic diseases (others than associated with PD)
- Clinical moderate to severe sleep-wake disorders (e.g. RLS-Index≥20, sleep apnea index ≥ 15 or, PLM-Index ≥ 15 if associated with arousals assessed during clinical PSG (in the framework of the pre-DBS work-up) and the clinical presentation of a RLS)
- Atypical or secondary Parkinsonism
- Severe medical conditions as renal insufficiency, liver failure, or congestive heart failure
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
Show all 25Show fewer
- Regular use of benzodiazepines other long-acting central nervous system (CNS)-depressant substances or long-acting antidepressants
- Use of melatonin less than 1 day prior to recording session
- Substance or alcohol abuse (i.e. > 0.5 l wine or 1 l beer per day)
- High caffeine consumption (> 5 servings/day; including coffee, energy drink)
- Known or suspected drug- or medication abuse
- Hearing deficiency resulting in inability to hear the auditory stimuli during sleep (based on results of standard pure-tone threshold audiometry)
- Not tolerating AS during screening night
- Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
- Participation in another study with the intervention within the 30 days preceding, and during the present study
- Previous enrolment in the current study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
- Shift work (work during the night)
- Travelling more than 2 time zones in the last month before the intervention starts or during the intervention (start of intervention will be adapted to fit with this criteria)
- Lack of safe contraception, defined as: Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year are not considered as being of child bearing potential.
- During DBS implantation/ICU:
- Use of long-acting substances (i.e. long-lasting benzodiazepines, anti-depressants)
- Use of full anesthesia
- Atypical STN electrophysiology
- Miss-location of the DBS leads (location will be checked after surgery using SureTune™ Medtronic software based on CT and MRI)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, University Hospital Zurich
Zurich, 8091
About this study
Official title: Integration of Auditory Slow-Wave Stimulation Into Subthalamic Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease: A Proof-of-Concept Study
The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system.
Read the detailed description
The objective of this study is to validate the STN signal for slow-wave detection during auditory stimulation. To test this, the electrophysiological activity within the STN will be measured as local field potentials (LFP) using standard STN-DBS electrodes. To assess whether the recorded STN activity can be used for AS, the coherence analysis of cortical and STN slow waves will be performed.
At the screening consultation, the study physician will obtain written informed consent, confirm inclusion and exclusion criteria, and obtain entry questionnaires including demographics, medical history, and concomitant therapy. Following a successful screening consultation, the study physician will schedule a screening night at the sleep laboratory in the department of Neurology, University Hospital Zurich (USZ), during which clinical surface EEG (12-channel system, including EMG, ECG, and EOG) will be recorded and AS will be applied. To test the individual susceptibility to AS, ERPs to auditory stimuli and SWA change will be assessed.
If the screening night was successful, each patient will undergo a baseline consultation and 3 recording sessions.
During all 3 recording sessions, the patients will be asked about their subjective sleep quality and current mood, concomitant therapy (including LED), and MDS-UPDRS III will be performed by the study physician. The surgical implantation (which is not part of the current proposal) follows standardized clinical protocol and is applied in 2 steps. Sleep will be recorded simultaneously with clinical surface EEG and STN LFP in all 3 recording sessions (combined LFP-EEG recording) and AS will be performed based on slow-wave detected in the surface EEG.
In detail: In the first step, DBS leads are implanted in the STN, keeping the wires externalized. Following one night in the intensive or intermediate care unit for monitoring, patients will undergo a full-night combined LFP-EEG recording and AS (Recording Session 1), with LFP data collected from the externalized wires (DBS off). Next, the surgery will be completed by implantation of the neuromodulator and its connection to the DBS leads. Following the completion of the surgery, rehabilitation will start. The rehabilitation period will last for 2-5 weeks. At the end of the rehabilitation Recording Session 2 and 3 will take place. These recording session will be separated by 2-3 days and their order will be randomized and counterbalanced across participants. During Recording Session 2, combined LFP-EEG recording and AS will be performed during first 4 hours of the night sleep; STN LFP will be recorded with the implanted neurostimulator (DBS off). Recording Session 3 will be similar to Recording Session 2, but with DBS on (i.e. using DBS settings that were adjusted during rehabilitation). Because stable LFP recordings by PERCEPT™ PC neurostimulator is only possible for 4 hours, LFP sleep recordings during Recording Session 2 and 3 are limited to the first 4h of sleep. Surface EEG and AS, however, will be performed for the whole night after the LFP recoding end. Recording Sessions 2 and 3 will take place either at Clinic Lengg or in the USZ sleep laboratory (if the patient will be at a different rehabilitation center than Clinic Lengg).
Additionally, circadian rhythm will be assessed continuously throughout the interventions using actigraphy.
- Conditions
- Parkinson Disease
- Being tested
- Acoustic stimulation
- Keywords
- sleep, neurodegeneration, slow-wave sleep, deep brain stimulation
- Medical subject headings
- Parkinson Disease, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic stimulationDevice
In this project, the intervention is a presentation of low-volume non-arousing auditory stimuli during deep NREM sleep via attached headphones. Stimuli will be applied targeting the up-phase of slow waves to enhance sleep slow-wave activity.
Previous studies showed that this procedure does not lead to reduced sleep quality nor result in changed sleep architecture. Therefore, no negative consequences as a result of our intervention are to be expected. In fact, it is currently applied in several other studies including children, adults, and the elderly. Importantly, stimulation is not arousing, as the sounds presented during deep sleep are brief (50 ms) and at low volume (around 50 dB). In case of arousal during sleep (detected using the surface EEG signal), the volume will be adjusted.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Measurements | Experimental | LFP recording from STN using externalized wires or implanted neurostimulator, while simultaneously recording clinical surface EEG and applying AS during deep sleep. Receives: Device: Acoustic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of STN LFP correlates of cortical slow waves (i.e. 1-4 Hz, in the surface EEG)
The temporal relationships of the surface EEG and the LFP will be investigated using the event-related potentials (ERP) and cross-correlation analysis.
Measured: Through study completion, an average of 2 years
Comparing the slope of slow wave across the night between surface EEG and STN-LFP
In the EEG and the LFP recordings slow waves (0.5-4.5Hz) will be detected during all night NREM sleep. The slope of all detected slow-waves at the beginning of the night (i.e., first hour of sleep) will be compared to the slope of all detected slow waves at the end of the night (i.e., last hour of sleep) for the EEG and the LFP recordings separately. The overnight difference will be compared between the EEG and the LFP recordings.
Measured: Through study completion, an average of 2 years
Comparing the amplitude of slow wave across the night between surface EEG and STN-LFP
In the EEG and the LFP recordings slow waves (0.5-4.5Hz) will be detected during all night NREM sleep. The amplitude of all detected slow-waves at the beginning of the night (i.e., first hour of sleep) will be compared to the slope of all detected slow waves at the end of the night (i.e., last hour of sleep) for the EEG and the LFP recordings separately. The overnight difference will be compared between the EEG and the LFP recordings.
Measured: Through study completion, an average of 2 years
Comparing the incidence of slow wave across the night between surface EEG and STN-LFP
In the EEG and the LFP recordings slow waves (0.5-4.5Hz) will be detected during all night NREM sleep. The number of all detected slow-waves at the beginning of the night (i.e., first hour of sleep) will be compared to the number of all detected slow waves at the end of the night (i.e., last hour of sleep) for the EEG and the LFP recordings separately. The overnight difference will be compared between the EEG and the LFP recordings.
Measured: Through study completion, an average of 2 years
AS effect on SWA in the surface EEG and STN-LFP
Comparing SWA (EEG power between 0.5-4.5Hz) during ON and OFF windows between surface EEG and STN-LFP
Measured: Through study completion, an average of 2 years
AS effect on the slope of slow waves in the surface EEG and STN-LFP
Comparing the slope of slow waves of all detected slow waves during ON compared to the slope of slow waves of all detected slow waves during OFF windows between surface EEG and STN-LFP
Measured: Through study completion, an average of 2 years
AS effect on the amplitude of slow waves in the surface EEG and STN-LFP
Comparing the amplitude of slow waves of all detected slow waves during ON compared to the slope of slow waves of all detected slow waves during OFF windows between surface EEG and STN-LFP
Measured: Through study completion, an average of 2 years
AS effect on frequencies over >4Hz
Comparing event-related potentials (ERP) between surface EEG and STN-LFP
Measured: Through study completion, an average of 2 years
AS effect on frequencies over >4Hz
Comparing time-frequency analysis of event-related spectral power (ERSP) between surface EEG and STN-LFP
Measured: Through study completion, an average of 2 years
AS effect on frequencies over >4Hz
Comparing inter-trial phase coherence (ITPC) between surface EEG and STN-LFP
Measured: Through study completion, an average of 2 years
Secondary outcomes (5)
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., total number of stimuli presented
Number of presented tones will be compared between Recording Session 1, 2 and 3
Measured: Through study completion, an average of 2 years
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., phase targeting of AS
Accuracy of slow-wave phase targeting during AS will be compared between Recording Session 1, 2 and 3
Measured: Through study completion, an average of 2 years
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., characterization of detected slow-waves
The slope of detected slow-waves will be compared between Recording Session 1,2 and 3
Measured: Through study completion, an average of 2 years
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., characterization of detected slow-waves
the amplitude of detected slow-waves will be compared between Recording Session 1,2 and 3
Measured: Through study completion, an average of 2 years
Investigation of relationships between behavioral performance changes and the AS effects (slow-wave characteristics in surface EEG and STN LFP) under DBS ON and OFF conditions
Comparing reaction time and response inhibition in the Go-NoGo Task between conditions and the evening and morning
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Nov 2021
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Baumann
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Lengg, Zurich, University Children's Hospital, University of Zurich
- Responsible party
- Sponsor-investigator, Christian Baumann, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184270
- Sponsor's protocol ID
- PD-LFP-AS
- Status last verified
- Sep 2023
- First submitted
- 15 Oct 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Auditory Slow-Wave Stimulation Into Subthalamic Deep Brain Stimulation to Enhance Deep Sleep in Parkinson's Disease: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT05184270
- Acronym / sponsor ID
- PD-LFP-AS
- Conditions
- Parkinson Disease
- Keywords
- sleep, neurodegeneration, slow-wave sleep, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Christian BaumannUniversity, hospital or other
- Collaborators
- Klinik Lengg, Zurich, University Children's Hospital, University of Zurich
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- 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 study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system.
Detailed description
The objective of this study is to validate the STN signal for slow-wave detection during auditory stimulation. To test this, the electrophysiological activity within the STN will be measured as local field potentials (LFP) using standard STN-DBS electrodes. To assess whether the recorded STN activity can be used for AS, the coherence analysis of cortical and STN slow waves will be performed.
At the screening consultation, the study physician will obtain written informed consent, confirm inclusion and exclusion criteria, and obtain entry questionnaires including demographics, medical history, and concomitant therapy. Following a successful screening consultation, the study physician will schedule a screening night at the sleep laboratory in the department of Neurology, University Hospital Zurich (USZ), during which clinical surface EEG (12-channel system, including EMG, ECG, and EOG) will be recorded and AS will be applied. To test the individual susceptibility to AS, ERPs to auditory stimuli and SWA change will be assessed.
If the screening night was successful, each patient will undergo a baseline consultation and 3 recording sessions.
During all 3 recording sessions, the patients will be asked about their subjective sleep quality and current mood, concomitant therapy (including LED), and MDS-UPDRS III will be performed by the study physician. The surgical implantation (which is not part of the current proposal) follows standardized clinical protocol and is applied in 2 steps. Sleep will be recorded simultaneously with clinical surface EEG and STN LFP in all 3 recording sessions (combined LFP-EEG recording) and AS will be performed based on slow-wave detected in the surface EEG.
In detail: In the first step, DBS leads are implanted in the STN, keeping the wires externalized. Following one night in the intensive or intermediate care unit for monitoring, patients will undergo a full-night combined LFP-EEG recording and AS (Recording Session 1), with LFP data collected from the externalized wires (DBS off). Next, the surgery will be completed by implantation of the neuromodulator and its connection to the DBS leads. Following the completion of the surgery, rehabilitation will start. The rehabilitation period will last for 2-5 weeks. At the end of the rehabilitation Recording Session 2 and 3 will take place. These recording session will be separated by 2-3 days and their order will be randomized and counterbalanced across participants. During Recording Session 2, combined LFP-EEG recording and AS will be performed during first 4 hours of the night sleep; STN LFP will be recorded with the implanted neurostimulator (DBS off). Recording Session 3 will be similar to Recording Session 2, but with DBS on (i.e. using DBS settings that were adjusted during rehabilitation). Because stable LFP recordings by PERCEPT™ PC neurostimulator is only possible for 4 hours, LFP sleep recordings during Recording Session 2 and 3 are limited to the first 4h of sleep. Surface EEG and AS, however, will be performed for the whole night after the LFP recoding end. Recording Sessions 2 and 3 will take place either at Clinic Lengg or in the USZ sleep laboratory (if the patient will be at a different rehabilitation center than Clinic Lengg).
Additionally, circadian rhythm will be assessed continuously throughout the interventions using actigraphy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Measurements | Experimental | Device: Acoustic stimulationLFP recording from STN using externalized wires or implanted neurostimulator, while simultaneously recording clinical surface EEG and applying AS during deep sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Diagnosis of PD along with international criteria with mild to moderate disease severity (Hoehn-Yahr (HY) stages ll-lll), selected for receiving STN-DBS therapy with the neurostimulator PERCEPT™
- Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
- Age above 18 years
- Negative pregnancy test during screening in female patients of childbearing potential (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year)
Key exclusion criteria (25 listed)
- Failure to give informed consent
- Known presence of neurologic (other than PD), psychiatric, or systemic diseases (others than associated with PD)
- Clinical moderate to severe sleep-wake disorders (e.g. RLS-Index≥20, sleep apnea index ≥ 15 or, PLM-Index ≥ 15 if associated with arousals assessed during clinical PSG (in the framework of the pre-DBS work-up) and the clinical presentation of a RLS)
- Atypical or secondary Parkinsonism
- Severe medical conditions as renal insufficiency, liver failure, or congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic stimulationIn this project, the intervention is a presentation of low-volume non-arousing auditory stimuli during deep NREM sleep via attached headphones. Stimuli will be applied targeting the up-phase of slow waves to enhance sleep slow-wave activity. Previous studies showed that this procedure does not lead to reduced sleep quality nor result in changed sleep architecture. Therefore, no negative consequences as a result of our intervention are to be expected. In fact, it is currently applied in several other studies including children, adults, and the elderly. Importantly, stimulation is not arousing, as the sounds presented during deep sleep are brief (50 ms) and at low volume (around 50 dB). In case of arousal during sleep (detected using the surface EEG signal), the volume will be adjusted. | Device | Sleep Measurements |
Primary outcome
Identification of STN LFP correlates of cortical slow waves (i.e. 1-4 Hz, in the surface EEG)
Time frame: Through study completion, an average of 2 years
The temporal relationships of the surface EEG and the LFP will be investigated using the event-related potentials (ERP) and cross-correlation analysis.
Comparing the slope of slow wave across the night between surface EEG and STN-LFP
Time frame: Through study completion, an average of 2 years
In the EEG and the LFP recordings slow waves (0.5-4.5Hz) will be detected during all night NREM sleep. The slope of all detected slow-waves at the beginning of the night (i.e., first hour of sleep) will be compared to the slope of all detected slow waves at the end of the night (i.e., last hour of sleep) for the EEG and the LFP recordings separately. The overnight difference will be compared between the EEG and the LFP recordings.
Comparing the amplitude of slow wave across the night between surface EEG and STN-LFP
Time frame: Through study completion, an average of 2 years
In the EEG and the LFP recordings slow waves (0.5-4.5Hz) will be detected during all night NREM sleep. The amplitude of all detected slow-waves at the beginning of the night (i.e., first hour of sleep) will be compared to the slope of all detected slow waves at the end of the night (i.e., last hour of sleep) for the EEG and the LFP recordings separately. The overnight difference will be compared between the EEG and the LFP recordings.
Comparing the incidence of slow wave across the night between surface EEG and STN-LFP
Time frame: Through study completion, an average of 2 years
In the EEG and the LFP recordings slow waves (0.5-4.5Hz) will be detected during all night NREM sleep. The number of all detected slow-waves at the beginning of the night (i.e., first hour of sleep) will be compared to the number of all detected slow waves at the end of the night (i.e., last hour of sleep) for the EEG and the LFP recordings separately. The overnight difference will be compared between the EEG and the LFP recordings.
AS effect on SWA in the surface EEG and STN-LFP
Time frame: Through study completion, an average of 2 years
Comparing SWA (EEG power between 0.5-4.5Hz) during ON and OFF windows between surface EEG and STN-LFP
AS effect on the slope of slow waves in the surface EEG and STN-LFP
Time frame: Through study completion, an average of 2 years
Comparing the slope of slow waves of all detected slow waves during ON compared to the slope of slow waves of all detected slow waves during OFF windows between surface EEG and STN-LFP
AS effect on the amplitude of slow waves in the surface EEG and STN-LFP
Time frame: Through study completion, an average of 2 years
Comparing the amplitude of slow waves of all detected slow waves during ON compared to the slope of slow waves of all detected slow waves during OFF windows between surface EEG and STN-LFP
AS effect on frequencies over >4Hz
Time frame: Through study completion, an average of 2 years
Comparing event-related potentials (ERP) between surface EEG and STN-LFP
AS effect on frequencies over >4Hz
Time frame: Through study completion, an average of 2 years
Comparing time-frequency analysis of event-related spectral power (ERSP) between surface EEG and STN-LFP
AS effect on frequencies over >4Hz
Time frame: Through study completion, an average of 2 years
Comparing inter-trial phase coherence (ITPC) between surface EEG and STN-LFP
5 secondary outcomes
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., total number of stimuli presented
Time frame: Through study completion, an average of 2 years
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., phase targeting of AS
Time frame: Through study completion, an average of 2 years
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., characterization of detected slow-waves
Time frame: Through study completion, an average of 2 years
Quantitative comparison of presented stimuli between recording sessions (i.e. DBS ON vs DBS OFF), i.e., characterization of detected slow-waves
Time frame: Through study completion, an average of 2 years
Investigation of relationships between behavioral performance changes and the AS effects (slow-wave characteristics in surface EEG and STN LFP) under DBS ON and OFF conditions
Time frame: Through study completion, an average of 2 years
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 21 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic stimulation in people with Parkinson Disease, run by Christian Baumann 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 5 inclusion and 25 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 21 Sep 2023. 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?
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?
Identification of STN LFP correlates of cortical slow waves (i.e. 1-4 Hz, in the surface EEG) (time frame: Through study completion, an average of 2 years). The study lists 10 primary outcomes in all. 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 21 Sep 2023.