NCT05034510

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

February 1, 2023

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

August 27, 2021

Last Update Submit

January 30, 2023

Conditions

Parkinson's Disease

Keywords

DBSParkinson's diseaselow frequencyshort pulse widthaxial symptoms

Outcome Measures

Primary Outcomes (2)

  • Freezing of gait incidence reduction

    change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3

    4 weeks

  • Improvement of freezing ratio

    change in freezing ratio

    4 weeks

Secondary Outcomes (2)

  • reduction of freezing of gait duration

    4 weeks

  • improvement in speech quality

    4 weeks

Study Arms (2)

Low frequency 80 Hz then short pulse width 30 usec stimulation

ACTIVE COMPARATOR

Each participant will undergo to low frequency stimulation for 4 weeks, then will switch to short pulse width stimulation paradigm for 4 weeks according to the crossover design.

Device: Deep Brain Stimulation

Short pulse width 30 usec then low frequency 80 Hz stimulation

ACTIVE COMPARATOR

Each participant will undergo to short pulse width stimulation paradigm for 4 weeks, then will switch to low frequency for 4 weeks according to the crossover design.

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

modification in stimulation parameters

Low frequency 80 Hz then short pulse width 30 usec stimulationShort pulse width 30 usec then low frequency 80 Hz stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ferrara - Arcispedale Sant'Anna

Ferrara, Emilia-Romagna, 44122, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Mariachiara Sensi, PhD

    Azienda Ospedaliero Universitaria di Ferrara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariachiara Sensi, PhD

CONTACT

0039-0532-237540mc.sensi@ospfe.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 5, 2021

Study Start

March 20, 2021

Primary Completion

March 20, 2023

Study Completion

March 20, 2024

Last Updated

February 1, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)