Condition category
Nervous System Diseases
Date applied
02/06/2006
Date assigned
15/09/2006
Last edited
01/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Clive Ballard

ORCID ID

Contact details

King's College London
Wolfson CARD
Guy's Campus
London
SE1 1UL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/10/2005

Study information

Scientific title

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)

Acronym

PECFC

Study hypothesis

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.

Ethics approval

South London and Maudsley NHS trust approved of protocol on 22 November 2005 (ref. no.: 05/Q0706/264).

Study design

Within-subjects comparison design testing a possible healthcare intervention where the sequence in which the different forms of care received are randomised.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Dementia

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reaction time standard deviation, measured at intervention.

Secondary outcome measures

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

Overall trial start date

01/07/2006

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

64

Participant 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

Recruitment start date

01/07/2006

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 1UL
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Guy's Campus
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

University/education

Funder name

King's College London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/03/2016: No publications found, verifying study status with principal investigator.