RBR-2h7szdg Music Therapy in the treatment of Parkinson's Disease: a pilot study

Date of registration: 03/25/2024 ^(mm/dd/yyyy)
Last approval date : 03/25/2024 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1295-6574

• Public title:

  en

  Music Therapy in the treatment of Parkinson's Disease: a pilot study

  pt-br

  Musicoterapia no tratamento da Doença de Parkinson: um estudo piloto

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 71560423.8.0000.0214
    Issuing authority: Plataforma Brasil
  • 6.287.086
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Paraná - Ciências Humanas e Sociais

Sponsors

• Primary sponsor: Universidade Federal do Paraná
• Secondary sponsor:
  • Institution: Universidade Federal do Paraná
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – CAPES

Health conditions

• Health conditions:

  en

  Parkinson's disease

  pt-br

  Doença de Parkison

• General descriptors for health conditions:

  en

  F02.463.188 Cognition

  pt-br

  F02.463.188 Cognição

• Specific descriptors:

  en

  C10.228.140.079.862.500 Parkinson's disease

  pt-br

  C10.228.140.079.862.500 Doença de Parkison

Interventions

• Interventions:

  en

  This is a pilot, single-arm, open masking study; with the collection of sociodemographic data (name, date of birth, gender, level of education); musical (formal experiences with music, frequency with which they listen to music, type of experience, musical preferences) and clinical (date of diagnosis, use of levodopa, use of deep brain stimulation implant, diagnosis of other clinical conditions and current therapies), from a group of 5 participants with Parkinson's disease included in a music therapy intervention program carried out over 30 days, with 3 sessions per week, lasting 30 minutes each, in which the participants listen to music and play musical instruments, with data collection before and after the intervention

  pt-br

  Trata-se de um estudo piloto, de braço único, de mascaramento aberto; com coleta de dados sociodemográficos (nome, data de nascimento, sexo, grau de escolaridade); musicais (experiências formais com música, frequência com que ouve música, tipo de experiência, preferências musicais) e clínicos (data do diagnóstico, uso de levodopa, uso de implante de estimulação cerebral profunda, diagnóstico de outros quadros clínicos e realização de terapias vigentes), de um grupo de 5 participantes com doença de Parkinson inseridos num programa de intervenção musicoterapêutica realizado durante 30 dias, sendo 3 atendimentos por semana, com duração de 30 minutos cada atendimento, em que os participantes ouvem músicas e tocam instrumentos musicais, com coleta de dados antes e após a intervenção

• Descriptors:

  en

  E02.190.888.500 Music Therapy

  pt-br

  E02.190.888.500 Musicoterapia

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 09/20/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  5	-	0	0

• Inclusion criteria:

  en

  Participants with an established diagnosis of idiopathic Parkinson's disease, in stages I to 99 on the Hoehn and Yahr scale, with a score greater than or equal to 26 at Montreal Cognitive Assessment- MoCA; both genders

  pt-br

  Participantes com diagnóstico estabelecido de doença de Parkinson idiopática, nos estágios de I a 99 na escala de Hoehn and Yahr, com pontuação maior ou igual a 26 no Montreal Cognitive Assessment - MoCA; ambos os gêneros

• Exclusion criteria:

  en

  Participants diagnosed with other neurological disorders; visual and/or auditory deficits that compromise understanding and carrying out the activities, and participants who are carrying out monitoring therapeutic for cognitive disorders

  pt-br

  Participantes diagnosticados com outras desordens neurológicas; deficits visuais e/ou auditivos que comprometam a compreensão e realização das atividades; e participantes que estejam realizando acompanhamento terapêutico para desordens cognitivas

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  Evaluate the recruitment rate, adherence rate, acceptance of the protocol, and other relevant information reported by researchers

  pt-br

  Avaliar a taxa de recrutamento, taxa de adesão, aceitação do protocolo, e demais informações relevantes relatadas pelos pesquisadores

• Secondary outcomes:

  en

  Evaluate the performance of inhibitory control in specific tests to investigate this ability

  pt-br

  Avaliar o desempenho do controle inibitório em testes específicos para averiguação de tal habilidade

Contacts

• Public contact
  • Full name: Amer Cavalheiro Hamdan
  • • Address: Praça Santos Andrade, 50
    • City: Curitiba / Brazil
    • Zip code: 80020-300
  • Phone: +55(41) 3360-5000
  • Email: amerc.hamdan@gmail.com
  • Affiliation: Universidade Federal do Paraná
   
• Scientific contact
  • Full name: Amer Cavalheiro Hamdan
  • • Address: Praça Santos Andrade, 50
    • City: Curitiba / Brazil
    • Zip code: 80020-300
  • Phone: +55(41) 3360-5000
  • Email: amerc.hamdan@gmail.com
  • Affiliation: Universidade Federal do Paraná
   
• Site contact
  • Full name: Amer Cavalheiro Hamdan
  • • Address: Praça Santos Andrade, 50
    • City: Curitiba / Brazil
    • Zip code: 80020-300
  • Phone: +55(41) 3360-5000
  • Email: amerc.hamdan@gmail.com
  • Affiliation: Universidade Federal do Paraná
   

Additional links:

• Download in ICTRP format