Effects of dual-target brain stimulation on Parkinson's Disease motor symptoms

Effects of dual-target Deep Brain Stimulation on motor function in individuals with Parkinson's Disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-3tjdn35

Enrollment

Registered

2026-08-05

Start date

2026-07-29

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&apos

Interventions

This is an exploratory, randomized, double-blind, self-controlled (crossover) clinical trial, developed as a master&apos

s degree project at the International Institute of Neuroscience Edmond and Lily Safra (IIN-ELS), of the Santos Dumont Institute (ISD), in which 10 patients with Parkinson&apos

s disease undergoing bilateral deep brain stimulation (DBS) implantation in the subthalamic nucleus (STN) and in the internal globus pallidus (GPi) will participate, with the same 10 participants bein

s Disease Rating Scale (UPDRS), the Timed-Up and Go test, and the Parkinson&apos

s Disease Questionnaire for quality-of-life assessment, with a neuropsychological assessment also being performed using standardized scales to identify cognitive and emotional changes resulting from s

s disease

Eligibility

Inclusion criteria

Inclusion criteria: Volunteers with time since Parkinson's Disease diagnosis of 5 years or more; surgical indication for dual target implantation by the neurologist or neurosurgeon; ability to walk independently; willingness to participate in the study and signature of the Informed Consent Form

Exclusion criteria

Exclusion criteria: Volunteers who present surgical or technical complications related to the DBS system implantation that prevent dual target implantation or require its removal; onset of dementia prior to stimulation or presence of decompensated psychiatric disorders

Design outcomes

Primary

Measure	Time frame
To evaluate the motor response to different deep brain stimulation conditions (dual-target, STN, and GPi) in patients with Parkinson's Disease. Assessed using the Unified Parkinson's Disease Rating Scale – Part III (UPDRS-III) and the Timed-Up and Go (TUG) functional test. Scores obtained on the UPDRS-III and the time, in seconds, recorded on the TUG-Test will be analyzed in each stimulation condition, comparing results across the three arms of the study	—

Measure

Time frame

To evaluate the motor response to different deep brain stimulation conditions (dual-target, STN, and GPi) in patients with Parkinson's Disease. Assessed using the Unified Parkinson's Disease Rating Scale – Part III (UPDRS-III) and the Timed-Up and Go (TUG) functional test. Scores obtained on the UPDRS-III and the time, in seconds, recorded on the TUG-Test will be analyzed in each stimulation condition, comparing results across the three arms of the study

—

Secondary

Measure	Time frame
To monitor the cognitive status of individuals following exposure to dual-target stimulation. Using standardized neuropsychological scales, including the Montreal Cognitive Assessment (MoCA), the Verbal Fluency Test, the Rey Auditory Verbal Learning Test, the Hamilton Depression Rating Scale (HAM-D), and the Five Digit Test. Possible changes in the scores of these scales will be observed between the baseline assessment and the assessment following exposure to dual-target stimulation;To monitor perioperative complications and adverse effects related to each stimulation mode. Through continuous clinical follow-up of participants throughout the entire experimental protocol. The number and type of adverse events and perioperative complications observed will be recorded in each arm of the study;To characterize cortical and subcortical structural changes in patients undergoing dual-target deep brain stimulation. Using the voxel-based morphometry (VBM) method based on magnetic resonance imaging. Differences in gray matter volume and density in the evaluated cortical and subcortical regions will be analyzed;To analyze the white matter tracts involved in the subthalamic nucleus (STN) and internal globus pallidus (GPi) circuits. Using tractography based on Diffusion Tensor Imaging. Tract integrity metrics, such as fractional anisotropy, and their correlation with the motor response to stimulation will be observed;To evaluate motor aspects related to activities of daily living under different stimulation conditions. Assessed using the Unified Parkinson's Disease Rating Scale – Part II (UPDRS-II). Scores obtained on the UPDRS-II will be analyzed in each of the three stimulation conditions (dual-target, STN, and GPi);To evaluate the impact on quality of life of different stimulation conditions. Using the Parkinson's Disease Questionnaire (PDQ-39). Scores obtained on the PDQ-39 will be analyzed in each stimulation condition, comparing results across the arms of the stud	—

Measure

Time frame

To monitor the cognitive status of individuals following exposure to dual-target stimulation. Using standardized neuropsychological scales, including the Montreal Cognitive Assessment (MoCA), the Verbal Fluency Test, the Rey Auditory Verbal Learning Test, the Hamilton Depression Rating Scale (HAM-D), and the Five Digit Test. Possible changes in the scores of these scales will be observed between the baseline assessment and the assessment following exposure to dual-target stimulation;To monitor perioperative complications and adverse effects related to each stimulation mode. Through continuous clinical follow-up of participants throughout the entire experimental protocol. The number and type of adverse events and perioperative complications observed will be recorded in each arm of the study;To characterize cortical and subcortical structural changes in patients undergoing dual-target deep brain stimulation. Using the voxel-based morphometry (VBM) method based on magnetic resonance imaging. Differences in gray matter volume and density in the evaluated cortical and subcortical regions will be analyzed;To analyze the white matter tracts involved in the subthalamic nucleus (STN) and internal globus pallidus (GPi) circuits. Using tractography based on Diffusion Tensor Imaging. Tract integrity metrics, such as fractional anisotropy, and their correlation with the motor response to stimulation will be observed;To evaluate motor aspects related to activities of daily living under different stimulation conditions. Assessed using the Unified Parkinson's Disease Rating Scale – Part II (UPDRS-II). Scores obtained on the UPDRS-II will be analyzed in each of the three stimulation conditions (dual-target, STN, and GPi);To evaluate the impact on quality of life of different stimulation conditions. Using the Parkinson's Disease Questionnaire (PDQ-39). Scores obtained on the PDQ-39 will be analyzed in each stimulation condition, comparing results across the arms of the stud

—

Countries

Contacts

Public ContactHougelle Simplicio Pereira

Instituto Santos Dumont

hougelle@gmail.com+55(84) 991558215

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Sep 19, 2026

Effects of dual-target brain stimulation on Parkinson&apos;s Disease motor symptoms