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

NCT02561715 | Withdrawn

• 1 other identifier: RG_14-096
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's; Anosognosia

Keywords

Parkinson's; Anosognosia; DBS; Deep Brain Surgery

Outcome Measures

Primary Outcomes (1)

• 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 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

  9 months

• Patient Generated Index

  9 months

• Abnormal Involuntary Movement Scale

  9 months

• Patient Competency Rating Scale

  9 months

• Grooved peg board test

  9 months

Interventions

Questionnaires BEHAVIORAL

Pre and post deep brain surgery questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's due for deep brain surgery

You may qualify if:

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

You may not qualify if:

• Unable to complete questionnaires in English.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Queen Elizabeth Hospital

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Agnosia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hardev Pall, MD

  Queen Elizabeth Medical Centre, Birmingham, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 28, 2015
• Study Start: August 1, 2015
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

GB (1)