Clinical trial NCT05034510: Short Pulse Width Versus Low Frequency DBS in Parkinson's Disease
Official title: A Double-Blind Randomized Crossover Comparison Of Short Pulse Width Versus Low Frequency For Axial Symptoms In Subthalamic Nucleus Deep Brain Stimulation (DBS)-Implanted Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: DBS
Parkinson's disease
low frequency
short pulse width
axial symptoms
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim is to compare the effect of reducing the conventional pulse width or frequency of stimulation for axial symptoms occurring after Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment. The participants will be assessed with chronic stimulation with conventional stimulation parameters, namely 60 us and 130 Hz, and after random allocation to short pulse width (30 us) or low frequency (80 Hz).

Detailed description: STN-DBS implanted patient frequently develop axial symptoms, such as gait and speech disorders, after this surgical procedure, which dampens long-term quality of life of Parkinson's disease patients. The pathogenesis is not completely understood, as it could be either due to a long-term stimulation side effect or a symptom with later onset in disease progression which is not well controlled with actual stimulation program. In case of freezing of gait onset in STN-DBS, literature suggest reducing stimulation frequency. Although, low pulse width is a promising option to tackle speech disorders after STN implant, it is not known its potential therapeutic potential on freezing of gait.

The aim of this investigation is to compare the effect of low frequency and short pulse width stimulation in patients, who develop axial symptoms during long-term follow-up in chronic conventional STN DBS.

As per protocol, participants will be assessed at baseline with chronic standard stimulation parameters (60 us and 130 Hz) then they will be randomly allocated either to a low-frequency (80Hz) or a low-pulse arm (30 us). The study is designed such that after scheduled re-assessment the participant will be switched from low frequency arm to short pulse width and vice versa according to the crossover nature of protocol design. Both the rating investigator and the participant are blinded to the allocation, whereas an unblinded investigator will modify the parameters according to allocation arm.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Subthalamic Nucleus Deep Brain Stimulation with chronic conventional stimulation at 60 usec and 130 Hz for at least 3 months
* Movement Disorder Society UPDRS part III 3.11 \>1
* Freezing of Gait Questionnaire item-3 \>1
* Movement Disorder Society UPDRS part III 3.1 \>1
* Montreal Cognitive Assessment \> 26
* No psychiatric disorders
* All patients will be ≥ 18 years of age
* Documented informed consent

Exclusion Criteria:

* no documented informed consent
* axial disorders not related to Parkinson's disease

Primary outcomes:
measure: Freezing of gait incidence reduction
timeFrame: 4 weeks
measure: Improvement of freezing ratio
timeFrame: 4 weeks
Secondary outcomes:
measure: reduction of freezing of gait duration
timeFrame: 4 weeks
measure: improvement in speech quality
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara - Arcispedale Sant'Anna
state: Emilia Romagna
Study officials:
affiliation: Azienda Ospedaliero Universitaria di Ferrara
name: Mariachiara Sensi, PhD
role: PRINCIPAL_INVESTIGATOR
References: