Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders

NCT ID: NCT04939818

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2022-09-15

Brief Summary

The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of self-assessment. Secondary objectives include (1) evaluating the reliability of speech tasks in the remote self-administered setting, as measured by the intra- and inter-subject variance; (2) accessing the adherence of speech tasks in this setting, as measured by the subject average fraction of days during the first week, where at least one task response is submitted; (3) evaluating the feasibility of using speech tasks in the setting of a telemedicine videoconference, as measured by the average length of speech elicited in each group; (4) evaluate whether a set of acoustic and linguistic patterns can detect each indication, compare to either a control group or all other indications, as measured by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5) evaluating how the performance of such algorithms can be impacted by speaker and environment covariates, as measured by the Kendall rank correlation coefficient of the AUC of each classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia With Lewy Bodies; Dementia, Vascular; Frontotemporal Dementia; Primary Progressive Aphasia; Parkinson Disease; Motor Neuron Disease; Major Depressive Disorder; Bipolar Disorder; Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1: Cognitive Disorders

Alzheimer's Disease (AD) Meet National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or Mild Alzheimer's Dementia

Dementia with Lewy bodies (DLB) Diagnosis of possible or probable DLB based on the criteria defined by The Dementia with Lewy Bodies Consortium (2015)

Non-AD non-DLB MCI Diagnosis of 'probable' and 'possible' behavioral variant frontotemporal dementia (bvFTD) according to the International Behavioral Variant FTD Criteria Consortium OR semantic variant or nonfluent-agrammatic variant primary progressive aphasia (PPA) FTD according to Mesulam's criteria OR Vascular Dementia according to NINDS-AIREN International Workshop

AND

Date of diagnosis not more than five years prior to consent Subjects must have MMSE scores of 23-30 (inclusive); or TICS40 score of 20-40 (inclusive) based on a test not older than 1 month at the time of consent.

Age of 50-85 years (inclusive)

No interventions assigned to this group

Group 2: Motor disorders

Parkinson's Disease (PD)

• Diagnosis of idiopathic Parkinson's Disease based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
• Date of diagnosis not more than five years prior to consent
• Hoehn and Yahr stage 2 or less
• Age of 30-85 years (inclusive)

Motor neuron Disease (MND)

• Diagnosis of Amyotrophic Lateral Sclerosis based on gold-standard clinical criteria
• Stage 3 or less on the King's ALS Staging system
• Age of 18-85 years (inclusive)

No interventions assigned to this group

Group 3: Affective disorders

Major Depressive Disorder (MDD)

• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current major depressive episode (MDE) as assessed by the MINI
• Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale.
• Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent.
• Age of 18-85 years (inclusive).

Bipolar Disorder (BD)

• Meet DSM-5 criteria for BD as assessed by the MINI (type 1 or type 2)
• Current depressive episode as assessed by the MINI
• Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale.
• Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent.

Age of 18-85 years (inclusive).

No interventions assigned to this group

Group 4: Unaffected Controls

Group 4 specific recruitment criteria matched for the 'Group 1: Cognitive Disorders' cohort:

• Age of 50-85 years (inclusive)
• Approximately age, gender and education matched to AD subjects on a group level.
• In otherwise good health condition.

Group 4 specific recruitment criteria matched for the 'Group 2: Motor Disorders' cohort:

• Age of 30-85 years (inclusive)
• Approximately age, gender and education matched to PD subjects on a group level.
• In otherwise good health condition.

Group 4 specific recruitment criteria matched for the 'Group 3: Affective Disorders' cohort:

• Age of 30-85 years (inclusive).
• Approximately age, gender and education matched to MDD/BD subjects on a group level.
• In otherwise good health condition.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Willing to participate, having been provided full information about the study components and details.
• Native language is English.
• Has the capacity to provide fully informed consent.
• Has access to and able to use, or has a caregiver who has access to and able to use a smartphone device running an operation system of iOS 11.0 or later, or Android 7.0 or later.
• Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
• Has access to a personal computer, notebook or tablet that is (1) Running an operating system of:

macOS X with macOS 10.9 or later; OR Windows 7 or above; AND (2) Capable of audio recording; AND (3) Able to connect to the internet; AND (4) Have access to one of following internet browser software: Internet Explorer version 11 or above; OR Microsoft Edge version 12 or above; OR Firefox version 27 or above; OR Google Chrome version 30 or above; OR Safari version 7 or above.

Exclusion Criteria

• Diagnosis of alcohol or drug use disorder;
• History or presence of stroke within the past 2 years;
• Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
• At risk of suicide: score of 10 or above on the PHQ scale, and 10 or above on the MINI suicide questionnaire

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Novoic Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan Young, Professor

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

South London and Maudsley NHS Foundation Trust

London, Greater London, United Kingdom

King's College Hospital NHS Foundation Trust

London, Greater London, United Kingdom

Countries

United Kingdom

References

Hampsey E, Meszaros M, Skirrow C, Strawbridge R, Taylor RH, Chok L, Aarsland D, Al-Chalabi A, Chaudhuri R, Weston J, Fristed E, Podlewska A, Awogbemila O, Young AH. Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders. BMJ Open. 2022 Jun 6;12(6):e061193. doi: 10.1136/bmjopen-2022-061193.

Reference Type: DERIVED

PMID: 35667724 (View on PubMed)

Other Identifiers

NOV-0200

Identifier Type: -

Identifier Source: org_study_id