Clinical trial NCT02561715: Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson's
Anosognosia
Keywords: Parkinson's
Anosognosia
DBS
Deep Brain Surgery
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's due for deep brain surgery

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unable to complete questionnaires in English.

Primary outcomes:
measure: Improvement of ability to recall extent of condition
timeFrame: 9 months
Secondary outcomes:
measure: 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
timeFrame: 9 months
measure: Patient Generated Index
timeFrame: 9 months
measure: Abnormal Involuntary Movement Scale
timeFrame: 9 months
measure: Patient Competency Rating Scale
timeFrame: 9 months
measure: Grooved peg board test
timeFrame: 9 months
measure: The tapping test
timeFrame: 9 months
measure: Unified Parkinson's Disease Rating Scale
timeFrame: 9 months
measure: Mini Mental State Exam
timeFrame: 9 months
measure: Parkinson's' Disease Questionnaire
timeFrame: 9 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Queen Elizabeth Medical Centre, Birmingham, UK
name: Hardev Pall, MD
role: PRINCIPAL_INVESTIGATOR
References: