Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Parkinson's disease is a progressive, degenerative neurological disease associated with
      profound changes in the quality of life of its survivors. Therapeutic exercises are widely
      employed in the attempt to delay or minimize disease progression, characterized by
      significant motor and sensory deficits. Recent evidence has demonstrated the potential use of
      transcranial direct current stimulation (TDCs) as a complement to therapeutic exercises.
      However, few studies have investigated the effects of TDCs combined with therapeutic
      exercises in patients with Parkinson's disease. This study aims to investigate the effect of
      TDCs combined with therapeutic exercises in people with Parkinson's disease. Thirty patients
      will be randomized into two distinct groups to receive either TDCs(anodal) + therapeutic
      exercises or TDCs (sham) + therapeutic exercises for 24 sessions over a five-week period. The
      primary clinical outcome (balance) and secondary outcomes (functional capacity, quality of
      life and perception of overall effect) will be collected before treatment after two and five
      weeks at month 3 and month 6 after randomization. The data will be collected by a blind
      examiner to the treatment allocation.
    

Detailed description: 
      In this study, a randomized, double-blind, placebo-controlled experimental design will be
      used. The 30 participants will be randomized into two groups: (1) TDCs(anodal) + therapeutic
      exercises and (2) TDCs (sham) + therapeutic exercises. The treatment will be performed for 8
      weeks, with three sessions per week, totaling 24 sessions of electrostimulation and
      therapeutic exercises. The primary variable (balance), secondary outcomes and other outcomes
      will be assessed before and after treatment. Follow-up of patients will be conducted at 8, 12
      and 24 weeks after randomization. All evaluations will be performed by a single researcher
      who, like the patients, will not know which stimulation group will be participating. Patients
      diagnosed with Parkinson's who seek treatment at the Clinical School of Physiotherapy of the
      Federal University of Piauí will receive detailed instructions on the present study. The
      physiotherapist responsible for evaluations will explain the objectives of the study,
      possible treatments, eligibility criteria and potential risks arising from the application of
      brain stimulation and therapeutic exercises. Patients who agree to the conditions and sign
      the consent form may participate in the study. Participants who meet the eligibility criteria
      will be included in the study.
    

Intervention name(s): tDCS; Exercise Therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Transcranial direct current stimulation is a modulation technique of neuronal excitability which has very promising results in Parkinson's disease. In addition to the possibility of increasing the excitability of areas to tDCS, it can also facilitate the execution of the exercises by increasing the excitability of the primary motor cortex and changing the recruitment strategies of the motor units.; Therapeutic exercises will be based on the literature (O'Sullivan and Schmitz 2004, Klamroth et al 2016, Reynolds et al., 2016, Pérez et al 2016, Smania et al., 2010, Pastor et al., 1993, Traub et al., 1980, Schoneburg et al., 2013) Each session will be divided into warm-up exercises; balance and relaxation, with a duration of 50 minutes and a frequency of 3 times a week. Training progresses and intensifies every two weeks. The subjects will perform five repeated movements of each exercise, evolving according to the condition of each patient (according to the Hoehn and Yahr staging scale).
Other intervention name(s): non invasive brain stimulation; Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, sham-controlled, clinical trial involving two types of intervention: (1) Physical therapy + active tDCS; (2) Physical therapy + sham tDCS.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; therapeutic exercises; Parkinson