Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's

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• Conditions: Parkinson's; Anosognosia

• Registration Number: NCT02561715
• Lead Sponsor: University of Birmingham

Brief Summary

Anosognosia is a recognised condition for people with Parkinson's, and is the result of physiological damage on brain structure.

Surgical Parkinson Disease Nurse Specialists have noticed that when reviewing the pre-surgery videos 12 months post-DBS, patients have forgotten and are shocked at how bad their symptoms were prior to surgery (personal communication), which may not be reflected in the change in QoL reported.

This lack of awareness, while possibly helpful in everyday life, may lead to effective treatments looking ineffective, or the benefits in QoL of effective treatment appearing reduced. This confound may not only reduce the apparent effectiveness but also the related cost-effectiveness of treatment. As cost-effectiveness is determined by both size and longevity of an effect, current methods of capturing these data may be suboptimal.

Detailed Description

The overarching aim of this project is to identify coping mechanisms and pathological lack of self-awareness and the impact they are likely to have on patient reported quality of life (QoL) outcome measures for a chronic condition.

This will be an observational study, a case series of approx. 10 to 20 patients. These patients will be recruited over a 6 month period from the Queen Elizabeth Hospital, Birmingham and will be informed of the study during their routine pre-surgical visit.

Patients will be eligible if they are about to undergo DBS at Queen Elizabeth Hospital. If the participant has a carer, who is also willing to participate, they may also join the study. Patients will be excluded if they are unable to complete questionnaires in English.

Once recruited and following consent, a patient will complete a brief battery of questionnaires both self-reported and clinician rated prior to surgery and at their 6 month post op visit.

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-28
• Primary Completion: 2019-07-18
• Study Completion: 2019-07-18
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Clinical diagnosis of Parkinson's as defined by the UK PDS Brain Bank Criteria

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Exclusion Criteria

• Unable to complete questionnaires in English.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of ability to recall extent of condition	9 months	Person with Parkinson's specific quality of life using the Parkinson's Disease Questionnaire for both participant and carer.

Secondary Outcome Measures

Name	Time	Method
Abnormal Involuntary Movement Scale	9 months	Occurrence of tardive dyskinesia
Grooved peg board test	9 months	Measuring motor performance
Unified Parkinson's Disease Rating Scale	9 months	Rating the extent of the participant's Parkinson's
Mini Mental State Exam	9 months	Measure of cognitive impairment
Clinician's Rating Scale for Evaluating Impaired Self Awareness and Denial of Disability after Brain Injury adapted for use with PD patients.after Brain Injury, adapted for use with Parkinson's Disease patients	9 months	Participants self-awareness of their Parkinson's
Patient Competency Rating Scale	9 months	Evaluation of self-awareness following traumatic brain injury
Patient Generated Index	9 months	Quality of life measure
The tapping test	9 months	Measuring motor control
Parkinson's' Disease Questionnaire	9 months	PDQ-39 (Carer)

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom