Clinical trial NCT01877148: Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease
Official title: Effects of Transcranial Direct Current Stimulation Associated With Physical Therapy on Motor Rehabilitation in Parkinson´s Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson, rehabilitation, tDCS
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to investigate the effect of transcranial direct current stimulation (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this way, this study will combine tDCS with physiotherapy in order to enhance the motor rehabilitation and the quality of life.

Detailed description: 12 patients were participated of this study.After screening to check the eligibility criteria and giving informed consent, they were randomized in two groups. All patients were submitted to a 10 therapeutic sessions that occurred 3 times per week.

Before, immediately after and 1 month after the last session patients were submitted to an evaluation with the follow tests: Unified Parkinson´s Disease Rating Scale(UPDRS), Jebsen Taylor Test (JTT) and Parkinson's Disease Quality of Life (PDQL). Furthermore, before and after each session the patients were submitted to transcranial magnetic stimulation (TMS) to evaluate cortical excitability through motor threshold and motor evoked potential.

In experimental sessions, the subjects always received physiotherapy with conventional techniques, the protocol followed the clinical practice guideline for physical therapy in Parkinson disease with the Royal Dutch Society Therapy. During tDCS protocol the patients seated in a comfortable chair with head and arm rests. Continuous current was applied using a pair of saline-soaked surface sponge electrodes (surface 35 cm2), the anode electrode was placed over the primary motor cortex and cathode above contralateral orbit. tDCS was applied of twice stimulation of 13 minutes with 20 minutes of interval between them and a current strength of 1mA. Sham tDCS was applied by current flow of 30s.

Eligibility criteria: Inclusion Criteria:

Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs against parkinson -

Exclusion Criteria:

pregnant history of convulsion metal implant in the region of skull or face change in medication during the study realize other physical therapy in the same time of the study previous surgery for parkinson disease

-

Primary outcomes:
measure: Change From Unified Parkinson´s Disease Rating Scale - UPDRS
timeFrame: At baseline, after 1 month
Secondary outcomes:
measure: Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation
timeFrame: per sesssion: at baseline and after physical therapy
Other outcomes:
measure: Change From Parkinson Disease Quality of Life - PDQL
timeFrame: at baseline, after 1 month
measure: Change From Jebsen-Taylor Hand Function Test - Jebsen Test
timeFrame: At baseline, after 1 month
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Kátia K Monte-Silva, PhD
role: STUDY_DIRECTOR
References: