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ISRCTN
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ISRCTN58368984
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ClinicalTrials.gov identifier
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Public title
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Psychological and Electrophysiological Correlates of dementia with Lewy bodies and Parkinson's disease dementia
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Scientific title
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A randomised, repeated measures investigation of rhythmic auditory cues as a potential intervention for attentional fluctuations in dementia with Lewy bodies (DLB)/Parkinson's disease dementia (PDD)
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Acronym
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PECFC
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Serial number at source
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10/10/2005
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Study hypothesis
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Dementia with Lewy bodies (DLB) accounts for 15% - 20% of late onset dementia whilst Parkinson's disease occurs in 1% of individuals over the age of 65; with at least 50% of these individuals developing symptoms of dementia (Parkinson's disease dementia - PDD). In addition to memory problems, people with these conditions experience persistent hallucinations, parkinsonian symptoms, marked problems with attention and fluctuating consciousness. Other symptoms that occur commonly include repeated falls, faints, temporary loss of consciousness, delusions and Rapid Eye Movement (REM) sleep behaviour disorder.
Rhythmic auditory cues can regulate attentional processes and fluctuating cognition in patients suffering from DLB or Parkinson's Disease Dementia (PDD) as reflected by a decrease in reaction time standard deviation variability in attentional tasks.
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Lay summary
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Ethics approval
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South London and Maudsley NHS trust approved of protocol on 22 November 2005 (ref. no.: 05/Q0706/264).
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Study design
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Within-subjects comparison design testing a possible healthcare intervention where the sequence in which the different forms of care received are randomised.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Dementia
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Participants - inclusion criteria
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1. Operationalised diagnosis of Dementia with Lewy Bodies (DLB), Parkinson’s Disease with Dementia (PDD), mild possible or probable Alzheimer’s Disease (AD), or Parkinson’s Disease (PD)
2. DLB and PDD patients must show clear signs of fluctuating cognition as indicated by a score eqaulling six on the One Day Fluctuation Assessment
3. Severity of dementia must be mild to moderate (Mini Mental State Examination [MMSE] greater than 14)
4. Capacity to give informed consent for participating in the study or Assent from Next of Kin (NOK)
5. Able to complete computerised test battery and understand instructions
6. Good hearing
7. Aged 63 - 89 years, either sex
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Participants - exclusion criteria
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1. Symptoms or disabilities that would result in difficulties fulfilling the test requirements
2. Any diagnosis of another medical condition that in the eyes or the experimentor or investigator would prohibit partaking in the study
3. Ability to undergo 12 hour washout period from anti-parkinsonian medication before cognitive testing
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Anticipated start date
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01/07/2006
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Anticipated end date
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01/10/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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64
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Interventions
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Baseline versus rhythmic auditory cue versus rhythmic auditory cue at increased volume - a one-off assessment comparing patients baseline performance with performance under different experimental conditions.
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Primary outcome measure(s)
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Reaction time standard deviation, measured at intervention.
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Secondary outcome measure(s)
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Measured at intervention:
1. Attentional performance
2. Reaction time
3. Tapping speed
4. Tracking precision
5. Electroencephalogram (EEG) mean frequency variability
6. Frequency of occurrence of stimulus independent thoughts
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Sources of funding
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King's College London (UK)
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Trial website
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Publications
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Contact name
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Prof
Clive
Ballard
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Address
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King's College London
Wolfson CARD
Guy's Campus
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City/town
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London
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Zip/Postcode
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SE1 1UL
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Country
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United Kingdom
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Sponsor
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King's College London (UK)
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Address
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Guy's Campus
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City/town
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London
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Zip/Postcode
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SE1 1UL
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Country
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United Kingdom
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Sponsor website:
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http://www.kcl.ac.uk/
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Date applied
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02/06/2006
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Last edited
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01/09/2009
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Date ISRCTN assigned
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15/09/2006
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