CsDCS on Functional Mobility in Parkinsons Disease

Cerebello-spinal Direct Current Stimulation Associated with Treadmill Gait Training in Functional Mobility in Patients with Parkinsons Disease

Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: cerebello-spinal direct current stimulation; Device: sham cerebello-spinal direct current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kátia Monte-Silva; Phone Number: 5581986450112; Email: monte.silvakk@gmail.com
• Study Contact Backup: Name: João Fabrício; Phone Number: 5581986450112; Email: joaovmelo2015@gmail.com

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-560
      • Recruiting
      • Universidade Federal de Pernambuco
      • Contact: João Fabrício

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• a clinical diagnosis of PD provided by a neurologist
• regular dopaminergic drug treatment (at least three months of use)
• aged 40 years or over
• staging I to IV on the modified Hoehn and Yahr scale

Exclusion Criteria:

• other neurological disorders, postural hypotension, vestibular, musculoskeletal or visual disorders that compromise performance in the proposed tests
• other osteoarticular diseases in the lower limbs that interfere with performance and locomotion
• a Montreal Cognitive Assessment (MoCA) score of less than 21 points
• have undergone previous surgery for PD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: csDCS	Device: cerebello-spinal direct current stimulation; Cerebello-spinal direct current stimulation is an electrical stimulus in the cerebellum as well as in the spinal cord that is used to improve functional mobility. To our knowledge, this is the first study to use this setup in individuals with Parkinsons disease.
Sham Comparator: csDCS sham	Device: sham cerebello-spinal direct current stimulation; Sham cerebello-spinal direct current stimulation involves masking, where the total duration of stimulation is thirty seconds, which is sufficient to mimic the sensation of stimulation but without neuromodulatory effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go	For the TUG, the time taken by the patient to perform a task involving standing up from a chair, walking, and sitting back down is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up, walks three meters at their fastest yet safe pace, turns around, returns to the chair, and sits down. Shorter times in completing this task indicate better functional mobility. Three repetitions of the test were recorded, and for analysis purposes, the average of the repetitions was used.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five times sit to stand test	For the TSL5, the time taken by the patient to perform the task of sitting and standing from a chair five times consecutively is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up and sits down five times at their fastest pace, but safely. Shorter times on this test indicate better functional mobility. The average of three attempts was used as the final result.	From enrollment to the end of treatment at 4 weeks
Mini balance evaluation system test	The abbreviated version of the Balance Evaluation System Test (miniBESTest) assesses static and dynamic balance through six different balance control mechanisms based on 14 specific activities of daily living. Each activity is rated from 0 (worst performance) to 2 (best performance) points. Thus, lower scores indicate poorer balance.	From enrollment to the end of treatment at 4 weeks
Unified Parkinson Disease Rating Scale-II and Scale-III	The motor function of the patients was assessed using the Unified Parkinsons Disease Rating Scale (UPDRS). The UPDRS is the most widely used clinical assessment tool for characterizing the motor symptoms of Parkinsons disease and for monitoring the progression of these symptoms and the physical disability caused by the disease. The UPDRS consists of 50 items, each rated from 0 to 4, ranging from the best (0) to the worst motor performance (4), and it is widely accepted for determining the efficacy of interventions in clinical studies. In the present study, Section II was used, which refers to the severity of the disease concerning the performance of activities of daily living. This section includes 13 items, each scored from 0 to 4, from the best to the greatest impairment. Section III of the UPDRS was also used, which corresponds to the motor examination and measures: resting tremor, postural tremor, rigidity, speech, facial expression, chair rise, posture, gait, postural stability	From enrollment to the end of treatment at 4 weeks
Freezing of gait questionnaire	The Freezing of Gait Questionnaire (FOG-Q) is a scale that assesses the individual's subjective perception of the severity and impact of freezing on their gait performance. The FOG-Q is classified on a 5-point scale (0 to 4), with a total score ranging from 0 to 24. A higher score indicates that the individual's gait performance is more affected by freezing.	From enrollment to the end of treatment at 4 weeks
Six minute walking test	In the 6MWT, the patient walks at their fastest, yet safe, pace along a 30-meter straight path for six minutes. At the end of the test, the total distance covered is calculated. Greater distances indicate better functional mobility.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Study Director: Kátia Monte-Silva, Universidade Federal de Pernambuco; Principal Investigator: João Fabrício, Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: parkinson disease; functional mobility; gait training; csDCS
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 78055423.8.1001.5208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No