CsDCS on Functional Mobility in Parkinsons Disease

NCT06856941 | Recruiting DMC

• 1 other identifier: 78055423.8.1001.5208
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

gait training; parkinson disease; functional mobility; csDCS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Five times sit to stand test

  From enrollment to the end of treatment at 4 weeks

• Mini balance evaluation system test

  From enrollment to the end of treatment at 4 weeks

• Unified Parkinson Disease Rating Scale-II and Scale-III

  From enrollment to the end of treatment at 4 weeks

• Freezing of gait questionnaire

  From enrollment to the end of treatment at 4 weeks

• Six minute walking test

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

csDCS

ACTIVE COMPARATOR

Device: cerebello-spinal direct current stimulation

csDCS sham

SHAM COMPARATOR

Device: sham cerebello-spinal direct current stimulation

Interventions

cerebello-spinal direct current stimulation DEVICE

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.

csDCS

sham cerebello-spinal direct current stimulation DEVICE

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

csDCS sham

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kátia Monte-Silva

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

• João Fabrício

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kátia Monte-Silva

CONTACT

5581986450112; monte.silvakk@gmail.com

João Fabrício

CONTACT

5581986450112; joaovmelo2015@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: May 9, 2024
• Primary Completion: July 1, 2025
• Study Completion: March 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2024-12

Locations

BR (1)