Trajectories of Outcome in Neurological Conditions (TONiC)

Trajectories of Outcome in Neurological Conditions (TONiC)

So far, about one in four people with motor neuron disease (MND) living in the UK have joined TONiC. The more people join and contribute their experiences and view points, the more powerful the results.

The results from TONiC will be used to improve services by identifying aspects of MND that are important to people living with MND, but which might be underestimated by current service provision. As part of TONiC we will develop 'outcome measures' that can be used for future studies.

People with MND at any stage of their illness are welcome to participate, the 'tick box' questionnaires are easily done at home at your own pace. If you cannot write, someone can tick your chosen response on your behalf. 

To take part, contact the local TONiC champion at a centre near you.

Visit the TONiC website

Contact the study team direct: +44 151 529 5668/2980 or e-mail tonic@thewaltoncentre.nhs.uk.

UK Chief Investigator

Professor Carolyn Young

Research summary

Quality of life (QoL) for people with disabling neurological conditions is affected by a range of factors, which have received considerable previous research attention. However, clinicians' knowledge could be enhanced by two areas of additional enquiry.

1. Wide consultation

• Interviewing a range of people with the conditions (first stroke, traumatic brain injury, multiple sclerosis, neuromyelitis optica, spinal conditions, MND) about factors influencing QoL.

• Multi-disciplinary panel – patients and clinicians – experienced in the conditions.

• Draft questionnaire assessed for relevance by people with the conditions.

• Our earlier work suggested the importance of QoL factors like fatigue. We will utilise suitable previously-validated condition-specific QoL measures. It is possible that invalidated or little-tested QoL factors will be suggested. If so, we will develop a new measure and test using.

• Focus groups – patients' and clinicians' opinions on QoL factors, and priority factors for analysis.

Such analysis would have greater validity than that used previously as it would reflect a wide range of patient and clinician opinion.

2. Testing factors for QoL influence

• Self-report questionnaire data from a large cross-section of people with the conditions.

• To assess QoL over time, questionnaire participants offered the choice to volunteer to complete the questionnaire 6 months, 12 months, and two years later.

Data would be analysed using statistical techniques to determine the nature and strength of relations between different factors.

The researchers will develop and test models of factors affecting QoL and compare whether models vary between conditions.

The model structure reflects World Health Organisation impairment, activity, and participation areas. The benefit of this approach is that we are testing factors which reflect concerns of people experienced in the conditions, to develop a model which may assist interventions to improve quality of life.

Inclusion / exclusion criteria

Inclusion criteria

1. Diagnosed with one of the following diseases: first stroke, traumatic brain injury (TBI), multiple sclerosis (MS),neuromyelitis optica (NMO), spinal conditions or MND.

2. Adults who are capable of answering questionnaires.

3. Capable of informed consent.

4. Have given informed consent.

5. For interviews, adults with the condition who are able to speak to a researcher, for any people with communication difficulties we will interview people with the assistance of a speech therapist or other support if necessary. For the questionnaire phase, we will not exclude people with difficulty writing due to their neurological condition and allow use of a scribe who records the answer chosen by the participant.

6. Participants wanting to do the qualitative work and cross sectional questionnaire stage can be at any time after diagnosis and participants wanting to do the longitudinal questionnaires commence within one year of diagnosis.

Exclusion criteria

1. Not capable of informed consent.

2. Have not given informed consent.

3. Suffering from a concomitant serious medical or psychiatric condition.

Current status

Active – Recruiting

Locations

Sites recruiting MND patients:

England

• Barnstaple

• Basildon

• Brighton (site closed to recruitment)

• Bury St Edmunds

• Cambridge

• Cumbria Partnership Community Care

• Dartford

• Kings Lynn

• Leicester

• United Lincolnshire Hospitals NHS Trust

• Liverpool

• London (King's College Hospital)

• London (North East London NHS Foundation Trust)

• London (Northwick Park Hospital)

• London (Royal Free Hospital)

• Maidstone and Tunbridge Wells NHS Trust

• Newcastle

• Norwich

• Oxford

• Peterborough

• Plymouth

• Portsmouth

• Preston

• Salford

• Sheffield (site closed to recruitment)

• Southampton

• Stoke (Haywood Hospital)

• Stoke (Royal Stoke University Hospital)

• Wonford, Devon

• Worcester

• York

Scotland

Edinburgh

Wales

• Cardiff

• Cwm Taf Morgannwg University Health Board

• Llanelli

• Swansea

Information about study sites

Contact details

Coordinating centre telephone: 0151 529 5668 / 0151 529 2980

Email: tonic@thewaltoncentre.nhs.uk

Recruitment groups

Patients with neurological conditions

Recruitment targets

16,500 patients nationally (this includes patients with MND and patients with other neurological conditions).

Key dates

Recruitment start date: 1 June 2012

Planned recruitment end date: 30 June 2027.

Sponsor

Walton Centre for Neurology and Neurosurgery NHS Foundation Trust

Study design

Longitudinal, observational (questionnaire).

Intervention (if applicable)

Not applicable

Phase (if applicable)

Not applicable

Outcome measures

• To develop a biopsychosocial model of factors affecting quality of life (QoL) in different neurological conditions:

  • Multiple sclerosis (MS)

  • Motor neurone disease (MND)

  • Neuromuscular (NM) disorders

  • Traumatic brain injury (TBI)

  • Spinal conditions

  • First stroke and neuromyelitis optica (NMO)

• To examine the validity of the model over time.

• To develop scales that measure different aspects of QoL in neurological illnesses, where generic scales are not available.

• To test the validity of some existing generic measures.

Publications / Results reports

Lay summary of published papers

• How common is depression in motor neurone disease?, 2023.

Published papers

• Prevalence of depression in amyotrophic lateral sclerosis / motor neuron disease: multi-attribute ascertainment and trajectories over 30 months, 2023.

• Risk factors for social withdrawal in amyotrophiclateral sclerosis/motor neurone disease, 2018.

• Mapping ALSFRS-R and ALSUI to EQ-5D in patients with motor neuron disease, 2018.

• Development and validation of Spasticity Index – Amyotrophic lateral sclerosis, 2018.

• Economic studies in motor neurone disease: A systematic methodological review, 2017.

Platform presentations

• Professionals opinions on the physical factors affecting quality of life in multiple sclerosis and motor neurone disease: Pilot work from the Trajectories of Outcomes in Neurological Conditions study. O'Sullivan, B, Rose, N, Griffiths, J, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions (TONiC) study group (2013). Abstract in Journal of Neurology 2013;260, S1: 26. Presented at 23rd Meeting of the European Neurological Society, Barcelona, Spain. June 2013.

• Perceptions of quality of life in motor neurone disease: Views of patients and patient family support group. Qualitative results from the Trajectories of Outcome in Neurological Conditions study. Ando, H, Cousins, R, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions (TONiC) study group (2013). Abstract in Journal of Neurology 2013;260, S1: 23-24. Presented at 23rd Meeting of the European Neurological Society, Barcelona, Spain. June 2013.

• Understanding quality of life in motor neurone disease: Qualitative explanations from the Trajectories of Outcome in Neurological Conditions Study (TONiC). Ando, H, Cousins, R, Young, C A. Abstract in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 2013;14(sup2):7. DOI: 10.3109/21678421.2013.838413/011. Presented at 24th International Symposium on ALS/MND, Milan, Italy.

• The role of hope in MS and MND. Young, C A (2016). Presented at Palliative Care in Neurology, London, 2016.

• Physical and psychological influences upon quality of life in motor neurone disease/ALS. Young, C A, Mills, R J, Tennant, A on behalf of the Trajectories of Outcome in Neurological Conditions study group (2016). Abstract in Amyotrophic Sclerosis and Frontotemporal Degeneration 2016;17, S1: 26. Presented at 27th International Symposium on MND/ALS Dublin, 7-9 December 2016.

• Development and validation of Spasticity Index – Amyotrophic lateral sclerosis (SI-ALS). Young, C A for TONiC study group (2017). Presented at ABN, Liverpool, UK, 3-5 May 2017.

• Understanding quality of life in ALS/MND by modelling patient-reported outcomes. Young, C A for TONiC study group. Presented at 29th International Symposium on ALS/MND, Glasgow, Scotland, UK, 7-9 December 2018.

Posters

• Perceptions of quality of life in motor neurone disease: Views of patients and patient family support group. Qualitative results from the Trajectories of Outcome in Neurological Conditions study. Ando, H, Cousins, R, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions (TONiC) study group. Presented at 23rd Meeting of the European Neurological Society, Barcelona, Spain, 8-11 June 2013. Abstract in Journal of Neurology 2013;260, S1: 23-24.

• Bulbar symptoms as physical determinants of quality of life in patients with amyotrophic lateral sclerosis: A systematic review. Mohammad, M H, Young, C A on behalf of the TONiC study group, presented at 24th International Symposium on MND Milan, 6-8 December 2013

• Psychosocial factors affecting quality of life in motor neurone disease: A systematic review of the literature. Nee, L D, Goldstein, L H, Young, C A (2013). Presented at 24th International Symposium on MND, Milan, 6-8 December 2013

• Functioning, fatigue and psychosocial features of ALS/MND: Associations, change over time and impact on patient quality of life. Gibbons, C J, Young, C A on behalf of the TONiC study group, presented at 24th International Symposium on MND, Milan, 6-8 December 2013.

• What is unique about quality of life in motor neurone disease? A qualitative query. Young, C A, Ando, H, Cousins, R on behalf of the TONiC study group, presented at 25th International Symposium on MND, Brussels, 5-7 December 2014.

• ALS symptoms, disability and quality of life: Literature review and model generation. Aynsley, G, Goldstein, L, Young, C A (2014). Presented at 25th International Symposium on MND, Brussels, 5-7 December 2014.

• The patient experience of spasticity in motor neurone disease. Milinis, K, Young, C A, on behalf of the TONiC study group, presented at 25th International Symposium on MND, Brussels, 5-7 December 2014.

• The structure and use of the Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised. Young, C A, Tennant, A on behalf of the TONiC study group, presented at 26th International Symposium on MND, Orlando, 11–13 December 2015.

• The fatigue to quality of life relationship in MND: Is gender moderating the effect? Young, C A, Tennant, A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 26th International Symposium on MND, Orlando, 11–13 December 2015.

• Coping strategies used by people with MND. Holland, D, Mills, R J, Tennant, A, Young, C A on behalf of the Trajectories of Outcomes in Neurological Conditions study group, presented at 26th International Symposium on MND, Orlando, 11–13 December 2015.

• Psychological distress in motor neurone disease and its correlation with use of alcohol or drugs and other negative coping strategies. Holland, D, Mills, R J, Tennant, A, Young, C A on behalf of the TONiC group (2015), presented at 26th International Symposium on MND, Orlando, 11–13 December 2015.

• Coping strategies, gender and disease subtype in MND/ALS. Young, C A, Mills, R J, Tennant, A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Influences on quality of life for people with MND/ALS: Progress of the Trajectories Of Outcome in Neurological Conditions study. Young, C A, Dyas-Wolff, L, Tennant, A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Co-morbidities in people with motor neurone disease/ALS. Sangheli, A, Mills, R J, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Onset type and consequent health status in MND/ALS. Young, C A, Tennant, A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Stigma in people with motor neurone disease/ALS. Young, C A, Mc-Sloy Poli, C, Tennant, A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Depression and anxiety in people with motor neurone disease/ALS. James, E, Mills, R J, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• The WHO disability assessment scale in the measurement of activity and participation in motor neurone disease/ALS. James, E, Tennant, A, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Economic evaluations, cost studies and utility studies in motor neurone disease/ALS: A systematic methodological review. Moore, A, Hughes, D, Young, C A on behalf of the TONiC study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• The relationships between fatigue, sleep and disability in motor neurone disease. Mills, R J, Tennant, A, Young, C A on behalf of the Trajectories of Outcome in Neurological Conditions study group, presented at 27th International Symposium on MND/ALS, Dublin, 7-9 December 2016.

• Risk factors for social withdrawal in motor neurone disease/amyotrophic lateral sclerosis. Schlüter, D K, Tennant, A, Young, C A on behalf of the TONiC group, presented at 28th International Symposium on MND/ALS, Boston, 8-10 December 2017.

• Use of coping strategies in motor neurone disease/amyotrophic lateral sclerosis: Association with demographic and disease-related characteristics. Schlüter, D K, Mills, R, Young, C A on behalf of the TONiC group, presented at 28th International Symposium on MND/ALS, Boston, 8-10 December 2017.

• Physical and mental factors affecting perceived stigma amongst people with motor neuron disease/ALS. Edge, R, Young, C A on behalf of the TONiC group, presented at 28th International Symposium on MND/ALS, Boston, 8-10 December 2017.

• Associations between pain, mood and quality of life in motor neurone disease/amyotrophic lateral sclerosis. Edge, R, Au Yeung, J, Young, C A on behalf of the TONiC group, presented at 28th International Symposium on MND/ALS, Boston, 8-10 December 2017.

• Mapping to the EQ-5D-5L from clinical data in people with motor neurone disease/amyotrophic lateral sclerosis. Moore, A, Young, C A, Hughes, D on behalf of the TONiC group, presented at 28th International Symposium on MND/ALS, Boston, 8-10 December 2017.

• Risk factors for depression in motor neurone disease. Schlüter, D K, Miele, G, Mills, R, Young, C A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Neuropathic pain in ALS/MND. Syrimi, Z J, Mills, R J, Young, C A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Investigating depression and disability in a cross-sectional sample of people with ALS/MND. Granger, N, Schlüter, D K, Bredin, A, Mills, R J, Young, C A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Social factors and their contribution to quality of life in ALS/MND: A systematic review of the literature. Nee, L, Granger, N, Young, C A, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Smoking is associated with younger age of onset in motor neurone disease. Mills, R J, Tennant, A, Young, C A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Can you validly use a total ALSFRS-R score? A Rasch analysis to provide interval scale estimates. Young, C A, Paris-Davies, J, Mills, R J, Tennant, A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Coping in motor neurone disease/amyotrophic lateral sclerosis: Qualitative analysis of themes. Young, C A, Ando, H, Cousins, R on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Equity of access to riluzole for individuals with MND/ALS in the UK. Schlüter, D K, James, B E, Mills, R, Young, C A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• Hope in motor neurone disease/amyotrophic lateral sclerosis: Qualitative analysis of concepts and domains. Young, C A, Ando, H, Cousins, R on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.

• World Health Organisation Disability Assessment Schedule (WHODAS-2.0) in MND/ALS. James, E C A, Mills, R J, Tennant, A, Young, C A on behalf of TONiC study group, presented at 29th International Symposium on ALS/MND, Glasgow, 7-9 December 2018.