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
NCT number | NCT02561715 |
Other study ID # | RG_14-096 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2015 |
Est. completion date | July 18, 2019 |
Verified date | March 2020 |
Source | University of Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth Hospital | Birmingham |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham |
United Kingdom,
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 |
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