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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anosognosia; Parkinson's
• Intervention / Treatment: Behavioral: Questionnaires

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 Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's due for deep brain surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to complete questionnaires in English.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Investigators: Principal Investigator: Hardev Pall, MD, Queen Elizabeth Medical Centre, Birmingham, UK

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): July 18, 2019
• Study Completion (Actual): July 18, 2019

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson's; DBS; Anosognosia; Deep Brain Surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Parkinson Disease; Agnosia
• Other Study ID Numbers: RG_14-096