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

Anosognosia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02561715
• Other study ID #: RG_14-096
• Status: Withdrawn
• Start date: August 1, 2015
• Est. completion date: July 18, 2019

Study information

• Verified date: March 2020
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 18, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to complete questionnaires in English.

Related Conditions & MeSH terms

• Anosognosia
• Parkinson Disease
• Parkinson's

Intervention

Behavioral:
• Questionnaires
Pre and post deep brain surgery questionnaires

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

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