Clinical trial NCT06856941: CsDCS on Functional Mobility in Parkinsons Disease
Official title: Cerebello-spinal Direct Current Stimulation Associated with Treadmill Gait Training in Functional Mobility in Patients with Parkinsons Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: gait training
parkinson disease
functional mobility
csDCS
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Timed Up and Go
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Five times sit to stand test
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Mini balance evaluation system test
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Unified Parkinson Disease Rating Scale-II and Scale-III
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Freezing of gait questionnaire
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Six minute walking test
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Kátia Monte-Silva
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Pernambuco
name: João Fabrício
role: PRINCIPAL_INVESTIGATOR
References: