Parkinson's DiseaseBeatParkNCT02438124
Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study
A study testing Neuropsychological evaluation in people with Parkinson's Disease, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research. Nonetheless, it is still unclear which auditory information parameters (i.e. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Neuropsychological evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 y.o.
- to be able to understand the study aims and to agree to participate
- to have signed the consent form
- to be registered to social security system
- to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank)
- gait disorder clinically observable
Who cannot join
- pregnant or lactating woman
- high probability of non-compliance
- curators , authorship or advisers to person of full age Specific exclusion criteria for PD patients
- clinical signs of parkinsonian syndrome
- Mini Mental State Examination < 24/30 Specific exclusion criteria for controls
- neurological disease
- gait disorder
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Service de neurologie de la Clinique Beau Soleil
Montpellier, 34070
Cochen De Cock Valérie, MD, 06 09 04 35 05, valerie.cochen@gmail.com
- Recruiting
CIC
Montpellier, 34235
Florence Galtier, Doctor
Valérie Cochen De Cock, MD, 06 09 04 35 05, valerie.cochen@gmail.com
- Recruiting
Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du
Montpellier, 34235
Valérie Cochen de cock, MD, 06 09 04 35 05, valerie.cochen@gmail.com
Sophie Bayard
About this study
Official title: Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's
The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research.
Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.
Read more
Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:
- RAS complexity (i.e. metronome, amplitude modulated noise, music)
- RAS variability (i.e fixed, random, semi-random)
- RAS adapted in real-time to gait
Variability study:
To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
- Conditions
- Parkinson's Disease
- Being tested
- Neuropsychological evaluation
- Keywords
- Parkinson's disease, Rhythmic auditory stimulation, Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological evaluationBehavioural
The subjects are submitted in one hearing stimulus while they realize a walking test
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patient with Parkinson's Disease with walking test and neuropsychological evaluation Receives: Behavioral: Neuropsychological evaluation |
| Contrôle | Experimental | normal control with walking test and neuropsychological evaluation Receives: Behavioral: Neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait velocity
evaluation of walking speed between the different conditions
Measured: 2 days
Secondary outcomes (1)
spatio-temporal gait characteristics
evaluation of other walking parameters between the different conditions
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Valérie Cochen De Cock, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438124
- Sponsor's protocol ID
- 9193-2
- Acronym
- BeatPark
- Status last verified
- Jan 2016
- First submitted
- 30 Apr 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arias P, Cudeiro J. Effects of rhythmic sensory stimulation (auditory, visual) on gait in Parkinson's disease patients. Exp Brain Res. 2008 Apr;186(4):589-601. doi: 10.1007/s00221-007-1263-y. Epub 2008 Jan 23.
PubMed 18214453Arias P, Cudeiro J. Effect of rhythmic auditory stimulation on gait in Parkinsonian patients with and without freezing of gait. PLoS One. 2010 Mar 22;5(3):e9675. doi: 10.1371/journal.pone.0009675.
PubMed 20339591Blin O, Ferrandez AM, Pailhous J, Serratrice G. Dopa-sensitive and dopa-resistant gait parameters in Parkinson's disease. J Neurol Sci. 1991 May;103(1):51-4. doi: 10.1016/0022-510x(91)90283-d.
PubMed 1865232Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115.
PubMed 15300651Brown LA, de Bruin N, Doan JB, Suchowersky O, Hu B. Novel challenges to gait in Parkinson's disease: the effect of concurrent music in single- and dual-task contexts. Arch Phys Med Rehabil. 2009 Sep;90(9):1578-83. doi: 10.1016/j.apmr.2009.03.009.
PubMed 19735787Delignieres D, Torre K. Fractal dynamics of human gait: a reassessment of the 1996 data of Hausdorff et al. J Appl Physiol (1985). 2009 Apr;106(4):1272-9. doi: 10.1152/japplphysiol.90757.2008. Epub 2009 Feb 19.
PubMed 19228991Dujardin K, Sockeel P, Carette AS, Delliaux M, Defebvre L. Assessing apathy in everyday clinical practice with the short-form Lille Apathy Rating Scale. Mov Disord. 2013 Dec;28(14):2014-9. doi: 10.1002/mds.25584. Epub 2013 Jul 8.
PubMed 23836341Ebersbach G, Heijmenberg M, Kindermann L, Trottenberg T, Wissel J, Poewe W. Interference of rhythmic constraint on gait in healthy subjects and patients with early Parkinson's disease: evidence for impaired locomotor pattern generation in early Parkinson's disease. Mov Disord. 1999 Jul;14(4):619-25. doi: 10.1002/1531-8257(199907)14:43.0.co;2-x.
PubMed 10435499Elbers RG, van Wegen EE, Verhoef J, Kwakkel G. Is gait speed a valid measure to predict community ambulation in patients with Parkinson's disease? J Rehabil Med. 2013 Apr;45(4):370-5. doi: 10.2340/16501977-1123.
PubMed 23450464Gibb WR, Lees AJ. The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson's disease. J Neurol Neurosurg Psychiatry. 1988 Jun;51(6):745-52. doi: 10.1136/jnnp.51.6.745.
PubMed 2841426Godefroy O, Brigitte A, Philippe A, Mira DH, Olivier G, Didier le G, Rose-Marie M, Thierry M, Chrystele M, Blandine P, Bernard P, Philippe R; Groupe de Reflexion sur L'Evaluation des Fonctions EXecutives. [Frontal dysexecutive syndromes]. Rev Neurol (Paris). 2004 Oct;160(10):899-909. doi: 10.1016/s0035-3787(04)71071-1. French.
PubMed 15492716Hausdorff JM. Gait dynamics in Parkinson's disease: common and distinct behavior among stride length, gait variability, and fractal-like scaling. Chaos. 2009 Jun;19(2):026113. doi: 10.1063/1.3147408.
PubMed 19566273Hove MJ, Suzuki K, Uchitomi H, Orimo S, Miyake Y. Interactive rhythmic auditory stimulation reinstates natural 1/f timing in gait of Parkinson's patients. PLoS One. 2012;7(3):e32600. doi: 10.1371/journal.pone.0032600. Epub 2012 Mar 2.
PubMed 22396783Howe TE, Lovgreen B, Cody FW, Ashton VJ, Oldham JA. Auditory cues can modify the gait of persons with early-stage Parkinson's disease: a method for enhancing parkinsonian walking performance? Clin Rehabil. 2003 Jul;17(4):363-7. doi: 10.1191/0269215503cr621oa.
PubMed 12785243Hughes AJ, Daniel SE, Kilford L, Lees AJ. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry. 1992 Mar;55(3):181-4. doi: 10.1136/jnnp.55.3.181.
PubMed 1564476
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's
- ClinicalTrials.gov ID
- NCT02438124
- Acronym / sponsor ID
- BeatPark / 9193-2
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Rhythmic auditory stimulation, Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research.
Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.
Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:
- RAS complexity (i.e. metronome, amplitude modulated noise, music)
- RAS variability (i.e fixed, random, semi-random)
- RAS adapted in real-time to gait
Variability study:
To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Behavioral: Neuropsychological evaluationPatient with Parkinson's Disease with walking test and neuropsychological evaluation |
| Contrôle | Experimental | Behavioral: Neuropsychological evaluationnormal control with walking test and neuropsychological evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 y.o.
- to be able to understand the study aims and to agree to participate
- to have signed the consent form
- to be registered to social security system
- to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank)
Key exclusion criteria (7 listed)
- pregnant or lactating woman
- high probability of non-compliance
- curators , authorship or advisers to person of full age Specific exclusion criteria for PD patients
- clinical signs of parkinsonian syndrome
- Mini Mental State Examination < 24/30 Specific exclusion criteria for controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological evaluationThe subjects are submitted in one hearing stimulus while they realize a walking test | Behavioural | Contrôle, Patient |
Primary outcome
gait velocity
Time frame: 2 days
evaluation of walking speed between the different conditions
1 secondary outcome
spatio-temporal gait characteristics
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Results publication: PubMed 18214453Arias P, Cudeiro J. Effects of rhythmic sensory stimulation (auditory, visual) on gait in Parkinson's disease patients. Exp Brain Res. 2008 Apr;186(4):589-601. doi: 10.1007/s00221-007-1263-y. Epub 2008 Jan 23.
- Results publication: PubMed 20339591Arias P, Cudeiro J. Effect of rhythmic auditory stimulation on gait in Parkinsonian patients with and without freezing of gait. PLoS One. 2010 Mar 22;5(3):e9675. doi: 10.1371/journal.pone.0009675.
- Results publication: PubMed 1865232Blin O, Ferrandez AM, Pailhous J, Serratrice G. Dopa-sensitive and dopa-resistant gait parameters in Parkinson's disease. J Neurol Sci. 1991 May;103(1):51-4. doi: 10.1016/0022-510x(91)90283-d.
- Results publication: PubMed 15300651Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115.
- Results publication: PubMed 19735787Brown LA, de Bruin N, Doan JB, Suchowersky O, Hu B. Novel challenges to gait in Parkinson's disease: the effect of concurrent music in single- and dual-task contexts. Arch Phys Med Rehabil. 2009 Sep;90(9):1578-83. doi: 10.1016/j.apmr.2009.03.009.
- Results publication: PubMed 19228991Delignieres D, Torre K. Fractal dynamics of human gait: a reassessment of the 1996 data of Hausdorff et al. J Appl Physiol (1985). 2009 Apr;106(4):1272-9. doi: 10.1152/japplphysiol.90757.2008. Epub 2009 Feb 19.
- Results publication: PubMed 23836341Dujardin K, Sockeel P, Carette AS, Delliaux M, Defebvre L. Assessing apathy in everyday clinical practice with the short-form Lille Apathy Rating Scale. Mov Disord. 2013 Dec;28(14):2014-9. doi: 10.1002/mds.25584. Epub 2013 Jul 8.
- Results publication: PubMed 10435499Ebersbach G, Heijmenberg M, Kindermann L, Trottenberg T, Wissel J, Poewe W. Interference of rhythmic constraint on gait in healthy subjects and patients with early Parkinson's disease: evidence for impaired locomotor pattern generation in early Parkinson's disease. Mov Disord. 1999 Jul;14(4):619-25. doi: 10.1002/1531-8257(199907)14:43.0.co;2-x.
- Results publication: PubMed 23450464Elbers RG, van Wegen EE, Verhoef J, Kwakkel G. Is gait speed a valid measure to predict community ambulation in patients with Parkinson's disease? J Rehabil Med. 2013 Apr;45(4):370-5. doi: 10.2340/16501977-1123.
- Results publication: PubMed 2841426Gibb WR, Lees AJ. The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson's disease. J Neurol Neurosurg Psychiatry. 1988 Jun;51(6):745-52. doi: 10.1136/jnnp.51.6.745.
- Results publication: PubMed 15492716Godefroy O, Brigitte A, Philippe A, Mira DH, Olivier G, Didier le G, Rose-Marie M, Thierry M, Chrystele M, Blandine P, Bernard P, Philippe R; Groupe de Reflexion sur L'Evaluation des Fonctions EXecutives. [Frontal dysexecutive syndromes]. Rev Neurol (Paris). 2004 Oct;160(10):899-909. doi: 10.1016/s0035-3787(04)71071-1. French.
- Results publication: PubMed 19566273Hausdorff JM. Gait dynamics in Parkinson's disease: common and distinct behavior among stride length, gait variability, and fractal-like scaling. Chaos. 2009 Jun;19(2):026113. doi: 10.1063/1.3147408.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Cochen De Cock, MD principal investigator
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological evaluation in people with Parkinson's Disease, run by University Hospital, Montpellier at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie Cochen De Cock, MD (06 09 04 35 0, valerie.cochen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait velocity (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438124, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.