Public trial
RBR-3ksnxkm Comparative Study between Transcranial Direct Current Stimulation and Binaural Vibro-Acoustic Brain Stimulation in Parki...
Date of registration: 06/28/2023 (mm/dd/yyyy)Last approval date : 06/28/2023 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Comparative study between transcranial direct current stimulation and binaural vibro-acoustic brain stimulation in Parkinson's patients
pt-br
Estudo Comparativo entre a Estimulação Transcraniana com Corrente Contínua e a Estimulação Cerebral Vibro-Acústica Binaural nos pacientes com Parkinson
es
Comparative study between transcranial direct current stimulation and binaural vibro-acoustic brain stimulation in Parkinson's patients
Trial identification
- UTN code:
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Public title:
en
Comparative Study between Transcranial Direct Current Stimulation and Binaural Vibro-Acoustic Brain Stimulation in Parkinson's
pt-br
Estudo Comparativo entre a Estimulação Transcraniana com Corrente Contínua e a Estimulação Cerebral Vibro-Acústica Binaural no Parkinson
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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5.498.114
Issuing authority: Comitê de Ética em Pesquisa do Hospital Universitário Onofre Lopes da Universidade Federal do Rio Grande do Norte
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55717521.0.0000.5292
Issuing authority: Plataforma Brasil
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5.498.114
Sponsors
- Primary sponsor: Hospital Universitário Onofre Lopes
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Secondary sponsor:
- Institution: Hospital Universitário Onofre Lopes
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Supporting source:
- Institution: Hospital Universitário Onofre Lopes
Health conditions
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Health conditions:
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Parkinson's Disease
pt-br
Doença de Parkinson
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General descriptors for health conditions:
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C10.228.140.079.862 Parkinsonian Disorders
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C10.228.140.079.862 Transtornos Parkinsonianos
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Specific descriptors:
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C10.228.140.079.862.500 Parkinson's Disease
pt-br
C10.228.140.079.862.500 Doença de Parkinson
Interventions
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Interventions:
en
The study will be a randomized, controlled, uni blinded, two-group clinical trial with a sample of 42 subjects, of both sexes, aged between 55 and 70 years, diagnosed with Parkinson's, in grades 2 or 3. The subjects will be evaluated and randomized from the www.randomizer.com website, and allocated in two groups in a confidential way, by sealed and increasingly named envelopes, which will be filled with the coding referring to the dosi groups described below: The Experimental Group, which will consist of 21 people treated with Binaural Vibroacoustic Brain Stimulation associated with treadmill gait training. And the control group, formed by 21 subjects treated with Transcranial Direct Current Stimulation. Both will receive treatment for four weeks, three times a week, totaling 12 appointments. Later they will be reassessed, obeying the same initial evaluation criteria. After 60 days, they will be called for a final evaluation, in the same way as the previous ones, for Follow up purposes.
pt-br
O estudo será um ensaio clínico, randomizado, controlado, uni cego, de dois grupos, com amostra de 42 sujeitos, de ambos os sexos, com idades entre 55 e 70 anos, com diagnóstico de Parkinson, em graus 2 ou 3. Os sujeitos serão avaliados e aleatorizados a partir do site www.randomizer.com, e alocados em dois grupos de forma sigilosa, mascarados por envelopes selados e numerados de modo crescente, que serão preenchidos com a codificação referente aos dois grupos descritos a seguir: O Grupo Experimental, que será composto de 21 sujeitos tratados com Estimulação Cerebral Vibroacústica Binaural associado ao treino de marcha em esteira. E o grupo controle, formado por 21 sujeitos tratados com Estimulação Transcraniana por Corrente Contínua. Ambos receberão tratamento por quatro semanas, três vezes por semana, totalizando 12 atendimentos. Posteriormente serão reavaliados, obedecendo os mesmos critérios avaliativos iniciais. Após 60 dias serão convocados para uma avaliação final, nos mesmos moldes das anteriores, para fins de Follow up.
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Descriptors:
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E02.190.888.030 Acoustic Stimulation
pt-br
E02.190.888.030 Estimulação Acústica
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F04.669224650 Transcranial Direct Current Stimulation
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F04.669224650 Estimulação Transcraniana por Corrente Contínua
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 04/01/2023 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 42 - 55 Y 70 Y -
Inclusion criteria:
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Have a diagnosis of Parkinson's Disease; in stage 2 or 3 of the disease; both genders; being between 55 and 70 years old; with independent gait
pt-br
Ter diagnóstico de Doença de Parkinson; em fase 2 ou 3 da doença; ambos os gêneros; estar entre 55 e 70 anos; com marcha independente
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Exclusion criteria:
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Make use of Deep Brain Stimulation; make use of cochlear implants; having uncontrolled labyrinthitis; having uncontrolled hypertension
pt-br
Fazer uso de Estimulação Cerebral Profunda; fazer uso de implante coclear; ter labirintite não controlada; ter hipertensão não controlada
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Parallel 2 Single-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
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It is expected to find a better response in the gait performance of subjects with Parkinson's treated with Vibroacoustic Brain Stimulation, compared to those treated with Transcranial Direct Current Stimulation
pt-br
Espera-se encontrar melhor resposta no desempenho da marcha dos sujeitos com Parkinson tratados com Estimulação Cerebral Vibroacústica, frente aos tratados com Estimulação Transcraniana por Corrente Contínua
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Secondary outcomes:
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It is expected to observe improvement in the posture of subjects with Parkinson's treated with Vibroacoustic Brain Stimulation, compared to those treated with Transcranial Direct Current Stimulation
pt-br
Espera-se observar melhora na postura dos sujeitos com Parkinson tratados com Estimulação Cerebral Vibroacústica, frente aos tratados com Estimulação Transcraniana por Corrente Contínua
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It is expected to observe improvement in the tremor of subjects with Parkinson's treated with Vibroacoustic Brain Stimulation, compared to those treated with Transcranial Direct Current Stimulation
pt-br
Espera-se observar melhora no tremor dos sujeitos com Parkinson tratados com Estimulação Cerebral Vibroacústica, frente aos tratados com Estimulação Transcraniana por Corrente Contínua
en
It is expected to observe improvement in the phenomenon of the arrest of subjects with Parkinson's treated with Vibroacoustic Brain Stimulation, compared to those treated with Transcranial Direct Current Stimulation
pt-br
Espera-se observar melhora no fenômeno da parada dos sujeitos com Parkinson tratados com Estimulação Cerebral Vibroacústica, frente aos tratados com Estimulação Transcraniana por Corrente Contínua
Contacts
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Public contact
- Full name: Gleidson Franciel Ribeiro de Medeiros
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- Address: Av. Elisa Branco Pereira dos Santos, 95
- City: Parnamirim / Brazil
- Zip code: 59158-160
- Phone: +55(84)988775494
- Email: dr.gleidsonmedeiros@gmail.com
- Affiliation: Hospital Universitário Onofre Lopes
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Scientific contact
- Full name: Gleidson Franciel Ribeiro de Medeiros
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- Address: Av. Elisa Branco Pereira dos Santos, 95
- City: Parnamirim / Brazil
- Zip code: 59158-160
- Phone: +55(84)988775494
- Email: dr.gleidsonmedeiros@gmail.com
- Affiliation: Hospital Universitário Onofre Lopes
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Site contact
- Full name: Gleidson Franciel Ribeiro de Medeiros
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- Address: Av. Elisa Branco Pereira dos Santos, 95
- City: Parnamirim / Brazil
- Zip code: 59158-160
- Phone: +55(84)988775494
- Email: dr.gleidsonmedeiros@gmail.com
- Affiliation: Hospital Universitário Onofre Lopes
Additional links:
Total de Ensaios Clínicos 16960.
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