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

Sponsor
Federal University of Minas Gerais
Study ID
NCT07567599
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — PROCEDURE
    Deep Brain Stimulation (DBS) is a stereotactic surgical technique used for the control and management of motor complications arising from L-dopa treatment. DBS consists of neural modulation through implanted electrodes connected to a neurostimulator (SHARMA et al., 2020). The fundamental criterion for surgical indication is refractoriness to conservative treatment. Of the four cardinal manifestations presented, three are suitable for surgical treatment: tremor, rigidity, and bradykinesia. The levodopa challenge test allows for an approximate assessment of the improvement that can be achieved with surgery; the ideal candidate is one who is severely impaired in the 'off' state and presents motor complications related to levodopa treatment or refractory tremor (HAMANI et al., 2008; FONOFF, 2012).

Study Details

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.

Key Dates

First listed
May 5, 2026
Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Deep Brain Stimulation
    Deep brain stimulation (DBS) surgery has consolidated itself in recent decades as an important therapeutic option for PD patients presenting with motor complications refractory to optimized pharmacological treatment. The procedure consists of the stereotactic implantation of electrodes into specific targets, such as the subthalamic nucleus (STN)-the most commonly used-or the internal globus pallidus (GPi), allowing for continuous, adjustable, and reversible electrical stimulation. The primary indication for DBS includes patients with motor fluctuations and levodopa-induced dyskinesias, or refractory tremor, provided they demonstrate a prior satisfactory response to levodopa and an absence of dementia or severe psychiatric comorbidities (Artusi et al., 2020; Hariz et al., 2022).

Primary Outcome Measure

Gait Speed [ Time Frame: Participants will be evaluated prior to Deep Brain Stimulation and at three- and six-month postoperative follow-ups ]

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