Parkinson DiseaseStimuLOOP_PD-SNCT07082595
Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study
A study testing TASS Intervention (Verum) in people with Parkinson Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by mobility deficits caused by impaired gait. 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?
- TASS Intervention (Verum)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jul 2025to 31 Mar 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
- Idiopathic Parkinson's disease with gait and postural stability deficits
- ≥18 years of age
- UPDRS III gait scores 1-3
- UPDRS III postural instability scores 1-3
- Prescribed rehabilitation therapy
- Informed consent as documented by signature
- Adjustments in dopaminergic medication and DBS stimulation to improve
Who cannot join
- Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20
- Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits
- History of a physical or neurological condition that interferes with study procedures
- Social and/or personal circumstances that interfere with the ability to return for assessments
- Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
- Recent DBS implant (≤ 6 months)
- Inability to perform outcome assessments without walking aid
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich
Zurich, Canton of Zurich, 8091
Angelina Maric, Dr. phil., +41 255 86 15, angelina.maric@usz.ch
Yannik Rottenberger, MSc, +41 255 56 45, yannik.rottenberger@usz.ch
About this study
Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by mobility deficits caused by impaired gait. Effective treatments are available to restore lower limb function and improve gait, but response to treatment varies greatly from patient to patient and often shows only small effect sizes. Addressing this heterogeneity requires personalization, a concept referred to precision neurorehabilitation.
StimuLOOP.PD-Sleep intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigators will conduct a proof-of-concept study to investigate a sleep intervention tailored to the individual patient in the context of motor rehabilitation.
Read more
- Targeted auditory stimulation during sleep (TASS): The investigators aim to reactive rehabilitation-related memories through presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands.
The investigators will leverage TASS to enhance consolidation of the movement patterns that are learned during rehabilitation.
The investigators expect that this intervention will lead to greater gains in functional walking ability and balance. Beyond demonstrating a proof-of-concept for novel methods of applying TASS stimulation in the context of neurorehabilitation, positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of TASS with a rehabilitation.
- Conditions
- Parkinson Disease
- Being tested
- TASS Intervention (Sham), TASS Intervention (Verum)
- Keywords
- Parkinson disease, Sleep, Neurorehabilitation, Auditory stimulation, StimuLOOP
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASS Intervention (Sham)Other
Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. No auditory stimuli will be delivered.
TASS Intervention (Verum)Other
TASS: Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. Auditory stimuli will be delivered through the integrated headphones when non-rapid-eye-movement (NREM) sleep is detected during the night to induce TASS.
| Study group | Role | What they receive |
|---|---|---|
| Sham arm | Sham comparator | Control targeted auditory stimulation during sleep during motor rehabilitation (TASS sham intervention) Receives: Other: TASS Intervention (Sham) |
| Verum arm | Experimental | Targeted auditory stimulation during sleep during motor rehabilitation (TASS verum intervention) Receives: Other: TASS Intervention (Verum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional walking ability
the change in functional walking ability assessed with the 6-minute walk test (6MWT)
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
postural stability
the change in postural stability assessed with the MiniBEST test measured before and after the intervention period.
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Secondary outcomes (5)
Phase Coordination Index
Motor learning assessed via changes in coordination. Coordination assessed using the Phase Coordination Index.
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Continuous Relative Phase
Motor learning assessed via changes in coordination. Coordination assessed using Continous Relative Phase.
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Variability
Motor learning assessed via changes in variability. Variability assessed using the coefficient of variation (%CV) of common spatio-temporal gait parameters, including stride time, stride length, step length, swing time, stance time, step width, and double limb support time.
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Symmetry
Motor learning assessed via changes in symmetry. Symmetry (%) in step length and step time.
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Margin of Stability
Motor learning assessed via changes in stability. Stability assessed using Margin of Stability
Measured: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start7 Jul 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082595
- Sponsor's protocol ID
- StimuLOOP_PD-S
- Other IDs
- 2024-01941
- Acronym
- StimuLOOP_PD-S
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study
- ClinicalTrials.gov ID
- NCT07082595
- Acronym / sponsor ID
- StimuLOOP_PD-S / StimuLOOP_PD-S
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Sleep, Neurorehabilitation, Auditory stimulation, StimuLOOP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Jul 2025 (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.
Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by mobility deficits caused by impaired gait. Effective treatments are available to restore lower limb function and improve gait, but response to treatment varies greatly from patient to patient and often shows only small effect sizes. Addressing this heterogeneity requires personalization, a concept referred to precision neurorehabilitation.
StimuLOOP.PD-Sleep intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigators will conduct a proof-of-concept study to investigate a sleep intervention tailored to the individual patient in the context of motor rehabilitation.
- Targeted auditory stimulation during sleep (TASS): The investigators aim to reactive rehabilitation-related memories through presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands.
The investigators will leverage TASS to enhance consolidation of the movement patterns that are learned during rehabilitation.
The investigators expect that this intervention will lead to greater gains in functional walking ability and balance. Beyond demonstrating a proof-of-concept for novel methods of applying TASS stimulation in the context of neurorehabilitation, positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of TASS with a rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham arm | Sham comparator | Other: TASS Intervention (Sham)Control targeted auditory stimulation during sleep during motor rehabilitation (TASS sham intervention) |
| Verum arm | Experimental | Other: TASS Intervention (Verum)Targeted auditory stimulation during sleep during motor rehabilitation (TASS verum intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Idiopathic Parkinson's disease with gait and postural stability deficits
- ≥18 years of age
- UPDRS III gait scores 1-3
- UPDRS III postural instability scores 1-3
- Prescribed rehabilitation therapy
Key exclusion criteria (8 listed)
- Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20
- Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits
- History of a physical or neurological condition that interferes with study procedures
- Social and/or personal circumstances that interfere with the ability to return for assessments
- Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
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 |
|---|---|---|
| TASS Intervention (Sham)Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. No auditory stimuli will be delivered. | Other | Sham arm |
| TASS Intervention (Verum)TASS: Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. Auditory stimuli will be delivered through the integrated headphones when non-rapid-eye-movement (NREM) sleep is detected during the night to induce TASS. | Other | Verum arm |
Primary outcome
functional walking ability
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
the change in functional walking ability assessed with the 6-minute walk test (6MWT)
postural stability
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
the change in postural stability assessed with the MiniBEST test measured before and after the intervention period.
5 secondary outcomes
Phase Coordination Index
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Continuous Relative Phase
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Variability
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Symmetry
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Margin of Stability
Time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TASS Intervention (Verum) in people with Parkinson Disease, run by University of 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 7 inclusion and 8 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 24 Jul 2025. 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. Some participants in this study may receive a placebo. 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 Christian Baumann, Prof. Dr. med. (+41 44 255 00 02, christian.baumann@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional walking ability (time frame: Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).). The study lists 2 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 24 Jul 2025.