An observational study in Parkinson's and Anosognosia, sponsored by University of Birmingham. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Birmingham · 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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
Browse Parkinson Disease studies →University of Birmingham is the lead sponsor of 179 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Parkinson's due for deep brain surgery
Exclusion Criteria:
Pre and post deep brain surgery questionnaires
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.
Time frame: 9 months
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
Time frame: 9 months
Patient Generated Index
Quality of life measure
Time frame: 9 months
Abnormal Involuntary Movement Scale
Occurrence of tardive dyskinesia
Time frame: 9 months
Patient Competency Rating Scale
Evaluation of self-awareness following traumatic brain injury
Time frame: 9 months
Grooved peg board test
Measuring motor performance
Time frame: 9 months
The tapping test
Measuring motor control
Time frame: 9 months
Unified Parkinson's Disease Rating Scale
Rating the extent of the participant's Parkinson's
Time frame: 9 months
Mini Mental State Exam
Measure of cognitive impairment
Time frame: 9 months
Parkinson's' Disease Questionnaire
PDQ-39 (Carer)
Time frame: 9 months
This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Birmingham