StimuLOOP.PD – Sensory-Motor Precision Neuro-Rehabilitation through Personalized Stimulation Loops for Patients with Parkinson's

Switzerland (ICTRP)

ID di studio ICTRP
NCT06608875 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Precision sensorimotor neurorehabilitation through personalized stimulation loops in a proof-of-principle study (BASEC)

Titolo accademico
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops in a Proof-of-principle Study (ICTRP)

Titolo pubblico
Precision Sensorimotor Neurorehabilitation Through Personalized Stimulation Loops (ICTRP)

Malattie studiate
Parkinson Disease (ICTRP)

Intervento studiato
Behavioral: Hyper-personalized feedback (HPF intervention);Behavioral: Targeted auditory stimulation during sleep (TASS verum intervention);Behavioral: Control targeted auditory stimulation during sleep (TASS sham intervention) (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:

- Idiopathic Parkinson's disease with gait and postural stability deficits

- =18 years of age

- United Parkinson Disease Rating Scale (UPDRS) III gait scores 1-3

- UPDRS III postural instability scores 1-3

- Prescribed rehabilitation therapy at cereneo

- Informed consent as documented by signature

- Adjustments in dopaminergic medication and deep brain stimulation (DBS) to improve
motor symptoms implemented to the current best possible extent

Exclusion Criteria:

- Cognitive impairment, Montreal Cognitive Assessment (MoCa) < 20

- Comprehensive aphasia precluding the understanding of study-related information

- Other neurological or medical condition that caused sustained clinically relevant
gait and/or postural stability deficits

- Expected acute hospitalization during the training period

- 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
therapy sessions and follow-up assessments

- Not capable of voluntary gait adaptation

- 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) (ICTRP)

non disponibile

Endpoint primari e secondari
6 min walking test;MiniBEST test (ICTRP)

Phase Coordination Index;Continuous Relative Phase;Variability;Symmetry;Margin of Stability;Resilience (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
ETH Zurich (Switzerland);Cereneo AG;University Children's Hospital, Zurich;Lake Lucerne Institute AG (ICTRP)

Contatti aggiuntivi
Angelina Maric, Angelina.Maric@usz.ch, +41 44 255 86 15 (ICTRP)

ID secondari
2023-01400 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06608875 (ICTRP)