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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy + anodal tDCS | Experimental | 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. |
|
| Physiotherapy + sham tDCS | Sham Comparator | The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline, after 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | per sesssion: at baseline and after physical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at baseline, after 1 month |
| Change From Jebsen-Taylor Hand Function Test - Jebsen Test |
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
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| Name | Affiliation | Role |
|---|---|---|
| Kátia K Monte-Silva, PhD | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Neuroscience Laboratory | Recife | Pernambuco | 50740-560 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | units on a scale | At baseline, after 1 month |
|
after tDCS
Questionnaire of adverses effects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kátia Monte-Silva | Universidade Federal de Pernambuco | + 55 (81) 2126-7579 | monte.silvakk@gmail.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
|
| Physiotherapy | Behavioral | 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. |
|
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 |
| At baseline, after 1 month |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| Secondary | Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation | Posted | Mean | Standard Error | milivolt | per sesssion: at baseline and after physical therapy |
|
|
|
| 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 | Posted | Mean | Standard Error | units on a scale | at baseline, after 1 month |
|
|
|
| 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 | Posted | Mean | Standard Error | minutes | At baseline, after 1 month |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 | 0 | 6 | 0 | 6 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012046 | Rehabilitation |