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Recruiting NCT06856941

CsDCS on Functional Mobility in Parkinsons Disease

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cerebello-spinal direct current stimulation, sham cerebello-spinal direct current stimulation.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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

Primary outcome measures

  • Timed Up and Go [Time frame: From enrollment to the end of treatment at 4 weeks]
Secondary outcome measures (5)
  • Five times sit to stand test [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Mini balance evaluation system test [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Unified Parkinson Disease Rating Scale-II and Scale-III [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Freezing of gait questionnaire [Time frame: From enrollment to the end of treatment at 4 weeks]
  • Six minute walking test [Time frame: From enrollment to the end of treatment at 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Universidade Federal de Pernambuco — Recife

Identifiers

NCT: NCT06856941 · 78055423.8.1001.5208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗