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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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18 June 2018 |
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Main ID: |
ISRCTN58368984 |
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Date of registration:
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15/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/07/2006 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN58368984 |
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Study type:
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Interventional |
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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. (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Clive
Ballard |
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Address:
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King's College London
Wolfson CARD
Guy's Campus
SE1 1UL
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dementia
Nervous System Diseases
Dementia
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Intervention(s)
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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(s)
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Reaction time standard deviation, measured at intervention.
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Secondary Outcome(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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Secondary ID(s)
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10/10/2005
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Source(s) of Monetary Support
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King's College London (UK)
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Ethics review
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Status:
Approval date:
Contact:
South London and Maudsley NHS trust approved of protocol on 22 November 2005 (ref. no.: 05/Q0706/264).
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/10/2008 |
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URL:
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