Parkinson'sNCT02561715
Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's
An observational study of Parkinson's and Anosognosia, run by University of Birmingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's, Anosognosia
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2015to 18 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's due for deep brain surgery
Who may be able to join
- Clinical diagnosis of Parkinson's as defined by the UK PDS Brain Bank Criteria
Who cannot join
- Unable to complete questionnaires in English.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's, Anosognosia
- Being tested
- Questionnaires
- Keywords
- Parkinson's, Anosognosia, DBS, Deep Brain Surgery
- Medical subject headings
- Parkinson Disease, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Pre and post deep brain surgery questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (9)
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
Measured: 9 months
Patient Generated Index
Quality of life measure
Measured: 9 months
Abnormal Involuntary Movement Scale
Occurrence of tardive dyskinesia
Measured: 9 months
Patient Competency Rating Scale
Evaluation of self-awareness following traumatic brain injury
Measured: 9 months
Grooved peg board test
Measuring motor performance
Measured: 9 months
The tapping test
Measuring motor control
Measured: 9 months
Unified Parkinson's Disease Rating Scale
Rating the extent of the participant's Parkinson's
Measured: 9 months
Mini Mental State Exam
Measure of cognitive impairment
Measured: 9 months
Parkinson's' Disease Questionnaire
PDQ-39 (Carer)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study start1 Aug 2015
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hardev Pall, MD, Principal investigator, Queen Elizabeth Medical Centre, Birmingham, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561715
- Sponsor's protocol ID
- RG_14-096
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2015
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02561715
- Acronym / sponsor ID
- RG_14-096
- Conditions
- Parkinson's, Anosognosia
- Keywords
- Parkinson's, Anosognosia, DBS, Deep Brain Surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's due for deep brain surgery
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson's as defined by the UK PDS Brain Bank Criteria
Key exclusion criteria (1 listed)
- Unable to complete questionnaires in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPre and post deep brain surgery questionnaires | Behavioural | – |
Primary outcome
Improvement of ability to recall extent of condition
Time frame: 9 months
Person with Parkinson's specific quality of life using the Parkinson's Disease Questionnaire for both participant and carer.
9 secondary outcomes
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
Time frame: 9 months
Patient Generated Index
Time frame: 9 months
Abnormal Involuntary Movement Scale
Time frame: 9 months
Patient Competency Rating Scale
Time frame: 9 months
Grooved peg board test
Time frame: 9 months
The tapping test
Time frame: 9 months
Unified Parkinson's Disease Rating Scale
Time frame: 9 months
Mini Mental State Exam
Time frame: 9 months
Parkinson's' Disease Questionnaire
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hardev Pall, MD principal investigator
Queen Elizabeth Medical Centre, Birmingham, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's and Anosognosia, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of ability to recall extent of condition (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.