Clinical trial NCT03473522: Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.
Official title: Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercises in Patients With Parkinson's Disease: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: Transcranial Direct Current Stimulation
therapeutic exercises
Parkinson
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
Collaborators: name: Foundation for Research Support of the State of Piauí
First posted: 2018-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From balance
timeFrame: 8 weeks after randomization
Secondary outcomes:
measure: Change From balance
timeFrame: 3 and 6 months after randomization
measure: Change From Unified Parkinson´s Disease Rating Scale
timeFrame: 8 weeks, 3 and 6 months after randomization
measure: Change From Parkinson Disease Quality of Life
timeFrame: 8 weeks, 3 and 6 months after randomization
measure: Change in the perception scale of the overall effect
timeFrame: 8 weeks, 3 and 6 months after randomization
measure: Maximal Isometric Voluntary Contraction
timeFrame: 8 weeks, 3 and 6 months after randomization
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: 8 weeks, 3 and 6 months after randomization
Other outcomes:
measure: Geriatric Depression Scale (GDS)
timeFrame: 8 weeks, 3 and 6 months after randomization
Locations:
city: Parnaíba
country: Brazil
facility: Universidade Federal do Piauí
state: PI
Study officials:
References: