Parkinson Disease
Conditions
Keywords
Parkinson, rehabilitation, tDCS
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.
Interventions
DEVICEtDCS
tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability.
BEHAVIORALPhysiotherapy
Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Unified Parkinson´s Disease Rating Scale - UPDRS | At baseline, after 1 month | Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome), as accurate and appropriate |
Secondary
| Measure | Time frame |
|---|---|
| Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | per sesssion: at baseline and after physical therapy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Parkinson Disease Quality of Life - PDQL | at baseline, after 1 month | Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome), as accurate and appropriate |
| Change From Jebsen-Taylor Hand Function Test - Jebsen Test | At baseline, after 1 month | The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physiotherapy + Anodal tDCS The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy | 5 |
| Physiotherapy + Sham tDCS The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Physiotherapy + Sham tDCS | Physiotherapy + Anodal tDCS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 68.2 years STANDARD_DEVIATION 11.75 | 59 years STANDARD_DEVIATION 9.27 | 63.6 years STANDARD_DEVIATION 10.51 |
| Region of Enrollment Brazil | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change From Unified Parkinson´s Disease Rating Scale - UPDRS
Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome), as accurate and appropriate
Time frame: At baseline, after 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy + Anodal tDCS | Change From Unified Parkinson´s Disease Rating Scale - UPDRS | Baseline | 24 units on a scale | Standard Error 12 |
| Physiotherapy + Anodal tDCS | Change From Unified Parkinson´s Disease Rating Scale - UPDRS | post 1 month | 21.2 units on a scale | Standard Error 11.12 |
| Physiotherapy + Sham tDCS | Change From Unified Parkinson´s Disease Rating Scale - UPDRS | Baseline | 30 units on a scale | Standard Error 23 |
| Physiotherapy + Sham tDCS | Change From Unified Parkinson´s Disease Rating Scale - UPDRS | post 1 month | 21.8 units on a scale | Standard Error 14 |
Secondary
Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation
Time frame: per sesssion: at baseline and after physical therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy + Anodal tDCS | Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | Baseline | 1.01 milivolt | Standard Error 0.25 |
| Physiotherapy + Anodal tDCS | Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | post 1 month | 1.35 milivolt | Standard Error 0.24 |
| Physiotherapy + Sham tDCS | Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | Baseline | 1 milivolt | Standard Error 0.22 |
| Physiotherapy + Sham tDCS | Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | post 1 month | 1.15 milivolt | Standard Error 0.31 |
Other Pre-specified
Change From Jebsen-Taylor Hand Function Test - Jebsen Test
The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function
Time frame: At baseline, after 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy + Anodal tDCS | Change From Jebsen-Taylor Hand Function Test - Jebsen Test | Baseline | 106.36 minutes | Standard Error 55.93 |
| Physiotherapy + Anodal tDCS | Change From Jebsen-Taylor Hand Function Test - Jebsen Test | post 1 month | 86.62 minutes | Standard Error 48.71 |
| Physiotherapy + Sham tDCS | Change From Jebsen-Taylor Hand Function Test - Jebsen Test | Baseline | 90.63 minutes | Standard Error 45.53 |
| Physiotherapy + Sham tDCS | Change From Jebsen-Taylor Hand Function Test - Jebsen Test | post 1 month | 81.29 minutes | Standard Error 27.5 |
Other Pre-specified
Change From Parkinson Disease Quality of Life - PDQL
Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome), as accurate and appropriate
Time frame: at baseline, after 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physiotherapy + Anodal tDCS | Change From Parkinson Disease Quality of Life - PDQL | Baseline | 112.8 units on a scale | Standard Error 44.1 |
| Physiotherapy + Anodal tDCS | Change From Parkinson Disease Quality of Life - PDQL | post 1 month | 120.2 units on a scale | Standard Error 35.07 |
| Physiotherapy + Sham tDCS | Change From Parkinson Disease Quality of Life - PDQL | Baseline | 117.2 units on a scale | Standard Error 45.6 |
| Physiotherapy + Sham tDCS | Change From Parkinson Disease Quality of Life - PDQL | post 1 month | 125.8 units on a scale | Standard Error 37.83 |