Digital App for Speech & Health Monitoring

Digital App for Speech & Health Monitoring in Neurodegenerative Disorders

Many people living with neurodegenerative conditions like dementia, motor neuron disease (MND), multiple sclerosis (MS), and Parkinson's disease (PD), suffer from speech problems. Using common digital technologies such as smartphone apps, the investigators can record and analyse speech in detail to provide new information for people living with these conditions, researchers, and healthcare professionals. This study will investigate the use of these digital speech recordings to help diagnose and monitor these conditions.

To take part, participants will have either a diagnosis of dementia, motor neuron disease, Parkinson's disease or Multiple Sclerosis, OR they will have no diagnosis of a neurological condition. Researchers will compare people with a diagnosis of a Neurological condition to those without.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Parkinson Disease; Motor Neuron Disease; Dementia

Detailed Description

This project aims to create novel speech-based solutions for: 1) Early detection, 2) Monitoring and 3) Stratification of neurodegenerative disorders including dementia, motor neuron disease (MND), Parkinson's disease (PD), and multiple sclerosis(MS). The investigators will develop and validate proof of concept and early-stage algorithms derived from acoustic data, which will be scaled and tested in deeply-phenotyped population.

2.2 Objectives Primary Objectives

1. To deploy and iterate a digital platform, co-produced with people living with neurodegenerative disorders, for acquisition of speech data from well characterised cohorts of people living with neurodegenerative disorders (dementia, motor neuron disease, multiple sclerosis, Parkinson's disease), and a healthy control cohort (comprising relatives/carers and volunteers without a neurological diagnosis), linked to our highly curated clinical registries at the Anne Rowling Regenerative Neurology Clinic.
2. To collect a large body of acoustic speech data from well characterised cohorts of people living with neurodegenerative disorders (dementia, MND/ALS, multiple sclerosis, Parkinson's disease), and a healthy control cohort (comprising relatives/carers and volunteers without a neurological diagnosis), linked to highly curated clinical registries.
3. To apply machine learning approaches directly to acoustic and linguistic signals from voices from people with dementia, MND, MS, Parkinson's, and healthy controls (comprising relatives/carers and volunteers without a neurological diagnosis), and to characterise prosodic patterns (rhythm, intonation, and fluency) without explicit reference to the text which is spoken, providing powerful cues about the health of the speaker.
4. Compare speech based digital outcome measures to current clinical standards to characterise and validate their clinimetric properties.

Secondary Objectives

1. Assess the feasibility and acceptability of a digital outcome measure platform in people living with neurodegenerative conditions, for use in clinical care and research.
2. To create a repository of well characterised acoustic voice samples for open access sharing/collaboration with research and industry partners.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Christine R Weaver, MSc; Phone Number: 01314659512; Email: cweaver@ed.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • NHS Lothian
    • Contact: Suvankar Pal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants with Neurodegenerative Disorders and their relatives or carers without a diagnosis of a Neurodegenerative disorder.

Description

Inclusion Criteria - Any one of the following:

• A person with a diagnosis of Motor Neuron Disease, Dementia, Multiple Sclerosis, or Parkinson's Disease.
• A relative or carer of the above who does not report to have a neurological condition.
• A healthy volunteer who does not report to have a neurological condition.

Exclusion Criteria:

• Age <16 years
• Significant and uncorrected visual or hearing impairment (precluding use of the App).
• Lack capacity to consent to project due to cognitive impairment (precluding understanding of the study and use of the App).

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Dementia
Parkinson's Disease
Multiple Sclerosis
Carers/Realtives/ Healthy - No Diagnosis of a Neurodegenerative Disorder
Motor Neuron Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome measures	Area under the curve (AUC) of the receiver operating characteristic (ROC) curve for each of the 4 binary classifiers distinguishing between a disease-positive group and a healthy control group.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome measure	Sensitivity, specificity, positive and negative predictive values for each of the 4 binary classifiers distinguishing between a disease-positive group and a healthy control group.	24 months
Secondary outcome measure	Mean squared error of 4 regression models making predictions of condition-specific clinical rating scores (ACE-III, ALSFRS-R, EDSS, MDS-UPDRS)	24 months

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian
• Investigators: Principal Investigator: Suvankar Pal, Prof, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Multiple Sclerosis; Parkinson Disease; Motor Neuron Disease; Dementia
• Other Study ID Numbers: AC24003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No