CsDCS on Functional Mobility in Parkinsons Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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csDCS

Group Type ACTIVE_COMPARATOR

cerebello-spinal direct current stimulation

Intervention Type 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

Group Type SHAM_COMPARATOR

sham cerebello-spinal direct current stimulation

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No