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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study to Examine the Effects of Anosognosia on Self-Reported Quality of Life for People With Parkinson's

Conditions
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Parkinson's, Anosognosia

Intervention / Treatment
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* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Parkinson's as defined by the UK PDS Brain Bank Criteria Exclusion Criteria: Unable to complete questionnaires in English.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Questionnaires|Pre and post deep brain surgery questionnaires|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of ability to recall extent of condition | Person with Parkinson's specific quality of life using the Parkinson's Disease Questionnaire for both participant and carer. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants self-awareness of their Parkinson's | 9 months | 
| Patient Generated Index | Quality of life measure | 9 months | 
| Abnormal Involuntary Movement Scale | Occurrence of tardive dyskinesia | 9 months | 
| Patient Competency Rating Scale | Evaluation of self-awareness following traumatic brain injury | 9 months | 
| Grooved peg board test | Measuring motor performance | 9 months | 
| The tapping test | Measuring motor control | 9 months | 
| Unified Parkinson's Disease Rating Scale | Rating the extent of the participant's Parkinson's | 9 months | 
| Mini Mental State Exam | Measure of cognitive impairment | 9 months | 
| Parkinson's' Disease Questionnaire | PDQ-39 (Carer) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's, Anosognosia, DBS, Deep Brain Surgery