Short Pulse Width Versus Low Frequency DBS in Parkinson's Disease

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034510
• Other study ID #: 203/2019/Disp/AOUFe
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: March 20, 2024

Study information

• Verified date: May 2022
• Source: University Hospital of Ferrara
• Contact: Mariachiara Sensi, PhD
• Phone: 0039-0532-237540
• Email: mc.sensi[@]ospfe.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep Brain Stimulation
modification in stimulation parameters

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara - Arcispedale Sant'Anna	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freezing of gait incidence reduction	change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3	4 weeks
Primary	Improvement of freezing ratio	change in freezing ratio	4 weeks
Secondary	reduction of freezing of gait duration	change of composite measure from item-4, item-5 and item-6 of Freezing of Gait Questionnaire	4 weeks
Secondary	improvement in speech quality	change in Movement Disorder Society UPDRS item 3.1	4 weeks