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Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease (ERA-EP2)

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ClinicalTrials.gov Identifier: NCT03278639
Recruitment Status : Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
National Council of Scientific and Technical Research, Argentina
Hospital Nacional Profesor Alejandro Posadas
University of Buenos Aires
Information provided by (Responsible Party):
Santiago Perez Lloret, Pontifical Catholic University of Argentina

Brief Summary:
Gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their movements to the rhythms. In this study, auditory stimuli will be constituted by Tango musical pieces, which tempo is modified to adapt to patients' walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance and may also improve Health-Related Quality of Life. This will be a randomized, blind, controlled clinical trial to further assess RAS efficacy and safety.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Rhythmic Auditory Stimulation Behavioral: Kinesiology Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, prospective, blind, controlled clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Both investigators taking care of patients and outcomes assessors will be blinded.
Primary Purpose: Treatment
Official Title: Randomized, Blind, Controlled Clinical Trial to Assess the Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rhythmic auditory stimulation
Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS.
Behavioral: Rhythmic Auditory Stimulation
Training will be directed to ameliorate gait and balance
Active Comparator: Kinesiology
Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS.
Behavioral: Kinesiology
Training will be directed to ameliorate gait and balance



Primary Outcome Measures :
  1. change from baseline in Tinetti scale total score [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. change from baseline in Tinetti scale Gait score [ Time Frame: 4 weeks ]
  2. change from baseline in Tinetti scale Balance score [ Time Frame: 4 weeks ]
  3. change from baseline in Tinetti scale total score [ Time Frame: 6 months ]
    training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.

  4. change from baseline in Timed Up & Go test (TUG) [ Time Frame: 4 weeks ]
  5. change from baseline in PDQ-39 scores [ Time Frame: 4 weeks ]
    PDQ-39 is a PD-specific scale for Health-related Quality of Life

  6. change from baseline in MDS-UPDRS score [ Time Frame: 4 weeks ]
    MDS-UPDRS is a measure of disease severity

  7. change from baseline in Beck Depression Index (BDI) [ Time Frame: 4 weeks ]
  8. change from baseline in MMSE (Mini-Mental State Examination) [ Time Frame: 4 weeks ]
    MMSE is a measure of cognitive impairment

  9. change from baseline in Fall diary [ Time Frame: 4 weeks ]
    patients will have to indicate the number of daily falls over a 15-d period


Other Outcome Measures:
  1. change from baseline in PD CRS [ Time Frame: 4 weeks and 6 months ]
    Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance

  2. change from baseline in DRS [ Time Frame: 4 weeks and 6 months ]
    Dementia Rating Scale (DRS) measures cognitive performance

  3. change from baseline in TUG [ Time Frame: 6 months ]
  4. change from baseline in PDQ-39 [ Time Frame: 6 months ]
  5. change from baseline in MDS-UPDRS [ Time Frame: 6 months ]
  6. change from baseline in BDI [ Time Frame: 6 months ]
  7. change from baseline in MMSE [ Time Frame: 6 months ]
  8. change from baseline in fall diary [ Time Frame: 6 months ]


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically definitive or probable PD diagnosis
  • Gait disorders (MDS-UPDRS #2.12 =1)
  • Patients that can be reasonably expected to remain in ON-state during training sessions.

Exclusion Criteria:

  • Previous use of RAS or kinesiology
  • MMSE >= 24
  • BDI >= 17
  • Patients having undergone PD surgical treatments.
  • Patients with auditory or visual handicaps

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278639


Contacts
Contact: Santiago Perez-Lloret, MD PhD 005491141834429 santiagopl@conicet.gov.ar

Locations
Argentina
Unidad de Neurocirugía Funcional, Hospital Nacional "Profesor Alejandro Posadas" Not yet recruiting
Buenos Aires, Argentina
Contact: Fernanda Lopez         
Sponsors and Collaborators
Pontifical Catholic University of Argentina
National Council of Scientific and Technical Research, Argentina
Hospital Nacional Profesor Alejandro Posadas
University of Buenos Aires
Investigators
Principal Investigator: Sergio Pampin, MD Hospital Nacional "Prof. Dr. A. Posadas"

Responsible Party: Santiago Perez Lloret, MD PhD CPI, Pontifical Catholic University of Argentina
ClinicalTrials.gov Identifier: NCT03278639     History of Changes
Other Study ID Numbers: ERAEP2
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Santiago Perez Lloret, Pontifical Catholic University of Argentina:
gait disorders
balance disorders
music
tango
rhythmic auditory stimulation
health-related quality of life

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases