Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.

Alessandra Tanuri Magalhães

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Device: tDCS; Behavioral: Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03473522

2.085.438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• medical diagnosis of idiopathic Parkinson's disease present for at least 12 months,
• spontaneous demand for treatment,
• in clinical follow-up and pharmacological treatment by a responsible physician,
• Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale,
• absence of cardiovascular diseases and musculoskeletal,
• signing of the free and informed consent form.

Exclusion criteria

• Use any associated orthopedic device to aid gait or balance control,
• signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE),
• diagnosis of other neurological disorders (including those of central and peripheral nature)
• previous treatment with tDCS,
• medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)
• the use of pacemakers or other implanted devices.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

anodal tDCS +Exercise Therapy

Experimental group

Description:

Anodal tDCS (2mA of intensity, for twenty minutes) over the motor cortex representation of trunk and lower limbs. Immediately after tDCS application all the patients will participate in an exercise therapy protocol involving balance control, strength,

Treatment:

Behavioral: Exercise Therapy

Device: tDCS

Sham tDCS+ Exercise Therapy

Sham Comparator group

Description:

Anodal tDCS (2mA of intensity, for twenty minutes but thirdy seconds ON) over the motor cortex representation of trunk and lower limbs.

Treatment:

Behavioral: Exercise Therapy

Device: tDCS