Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07567599 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Deep Brain Stimulation in Parkinson's Disease: Motor and Functional Outcomes

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Start date: Apr 28, 2026 to Jun 2, 2026
    • Primary and study completion pushed from Dec 5, 2026 to Feb 2027
    v3
  3. Minor Study description shortened, about 177 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Introduction: Parkinson's Disease (PD) is a progressive neurodegenerative condition characterized by classic motor symptoms, such as bradykinesia, rigidity, resting tremor, and postural instability, which directly compromise the mobility and autonomy of individuals with PD. Furthermore, non-motor manifestations, including autonomic, cognitive, and emotional changes, impact the quality of life of individuals with PD. Deep Brain Stimulation (DBS) surgery is a well-established treatment to assist in improving the primary motor symptoms of PD; however, literature is scarce in describing specific results regarding physiotherapeutic aspects, such as the motor symptoms that determine better quality of life and social participation for individuals with PD. Determining whether factors amenable to improvement prior to surgery-such as bradykinesia, muscle strength, and balance-are related to better motor and functional outcomes in individuals with PD post-DBS is of great importance to ensure a better result from the surgical intervention. Objective: To compare motor outcomes (gait speed, balance, freezing of gait, fear of falling, muscle strength, functional capacity, and physical activity level) of individuals with PD after undergoing DBS, relative to the motor status previously observed in the preoperative period. Methods: This is an uncontrolled clinical trial, with data collection conducted at the Neurovida private multidisciplinary clinic and the Hospital Santa Casa in Belo Horizonte. This study will be registered at www.clinicalTrials.gov and conducted according to the Consolidated Standards of Reporting Trials (CONSORT) recommendations. The present study will be submitted to the Research Ethics Committee of the Federal University of Minas Gerais (COEP) and will only commence after proper approval. All necessary consents for the development of the study have been obtained. The sample consists of individuals with idiopathic PD selected by a clinical neurologist specializing in movement disorders. The inclusion criteria for the present study are: having idiopathic PD diagnosed for more than five years, being under treatment with a neurologist specializing in movement disorders, and having an indication for DBS. Descriptive statistics and normality tests will be performed for all study variables. Selected variables will be compared in terms of mean difference between post- and pre-surgery measurements, considering a 95% CI. In all analyses, a significance level of α=0.05 will be considered, using the SPSS statistical package version 15.0 for Windows.
Trial Details
NCT Number NCT07567599
Lead Sponsor Federal University of Minas Gerais
Conditions
(from sponsor)
Parkinson Disease
Related terms Hypokinesia, Parkinson Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov