Dystonia Clinical Trial
Official title:
The Use of the CUE1 Device in People With Idiopathic Parkinson's Disease and Related Disorders: A Feasibility Study
People with Parkinson's disease (PD) commonly experience a range of both motor (e.g., bradykinesia, rigidity, tremor, and postural instability) and non-motor (e.g., fatigue, psychiatric and behavioural disturbances, autonomic dysfunction, cognitive impairment, sleep dysfunction and olfactory loss) features. Currently, it is challenging to alleviate these symptoms with first-line treatment, the medications such as levodopa. The CUE1 is a non-invasive device, which is approved for sale in the UK market as a Class I low risk device. It is worn on the sternum or other part of the body such as the forearm and attaches to the skin via an adhesive patch which has been dermatologically tested and approved. The CUE1 delivers pulsing cueing and vibrotactile stimulation to help improve symptoms in people with PD and it has shown to be effective in doing so in previous small case studies. This 9-week feasibility study aims to investigate the feasibility, safety, tolerability and effect of using the CUE1 as an intervention to improve motor and non-motor symptoms in people with PD and related movement disorders. People with clinical diagnosis of idiopathic PD and related disorders including those with progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, and vascular Parkinsonism as well as atypical dystonias and tremor disorders aged over 18 years old who have the capacity to provide a written consent form to take part in the study, will receive as intervention to wear the CUE1 device at home, on daily basis while carrying out their activities of daily living. Participants will also have to attend four face-to-face appointments of approximately half a day, at weeks -0, -3, -6 and -9 of the study to discuss how they are getting on with using the CUE1 and complete questionnaires on their symptoms, walking, balance, and movement tests as well as a participant's clinical diary.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults over 18 years old - Clinical diagnosis of idiopathic PD and related disorders including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD), and vascular Parkinsonism (VaP) as well as atypical dystonias and tremor disorders - willing to participate and written consent provided after read the participant information sheet. Exclusion Criteria: Individuals with: - other neurological disorders excluding idiopathic PD, related disorders such PSP, MSA, CBD, and VaP as well as atypical dystonias and tremor disorders, affecting movement, balance and gait - metabolic or autoimmune disorders affecting movement, balance and gait - acute orthopaedic disorders influencing balance control and gait - audiovestibular disorders including severe hearing loss - visual disturbances, poor eyesight - not able to provide written consent form to participate - clinical diagnosis of cognitive impairment including dementia or Alzheimer's. - Mental impairments (illusions, hallucinations, impulse control disorders) (self-reported) Technical contraindications related to CUE1 device: - implanted metallic or electronic devices usage - hypersensitivity to vibrotactile stimulation - skin conditions and/or open wound in the area of where the device will be positioned (e.g., sternum) if taking medicines for PD or related disorder, then on stable dose of treatment for the last three months. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Queen Mary University of London |
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* Note: There are 69 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | Age is recorded in years and collected as baseline demographic characteristic only. | within 1 minute | |
Other | Gender | Gender is recorded as male, female, and other, and collected as baseline demographic characteristic only. | within 1 minute | |
Other | Disease duration | The disease duration is recorded in years and collected as baseline demographic characteristic only. | within 1 minute | |
Other | Hoehn & Yahr (H &Y) | Hoehn & Yahr (H & Y) scale is used to record the disease severity for people with Parkinson's disease. | within 1 minute | |
Other | Montreal Cognitive Assessment (MoCA) tool | The MoCA is a rapid screening tool for mild cognitive impairment. It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. It has been recommended that cut-off scores of <26/30 be used to identify multi-domain cognitive impairment. | within 5 minutes | |
Other | Cognitive Behavioural Symptom Questionnaire (CBSQ) | The CBSQ is a measure of subjects' cognitive (i.e. beliefs) and behavioural responses to symptoms of their health condition. This measure includes five cognitive (i.e. beliefs) subscales: Symptom Focusing, Catastrophizing, Damaging Beliefs, Fear Avoidance and Embarrassment Avoidance; and two behavioural subscales: All or- Nothing and Avoidance/Rest. All items are rated on a 5-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. | within 5 minutes | |
Other | Illness Perception Questionnaire-Revised (IPQ-R) | The IPQ-R was used to measure participants' illness perceptions. The IPQ-R measures the key components in Leventhal's common sense self-regulatory model: Illness identity was measured by asking patients to indicate whether they have experienced and attribute a number of potential symptoms to their dizziness condition, with higher scores (range 0-24) indicating increased illness identity. In accordance with the recommendations from the authors, some items were added based on feedback from a patient-public involvement group so as to reflect the symptoms experienced by people with vestibular disorders. Causal Factors were measured by asking participants to list up to three things that they believed caused their condition. | within 5 minutes | |
Primary | Recruitment rate | This is a feasibility outcome, the recruitment rate which will be calculated as the percentage of eligible participants enrolled in the study. This will be reported at each follow up appointment at weeks -3, -6 and -9. | 1 minute | |
Primary | Compliance with interventions | This is a feasibility outcome, compliance with interventions, which will be reported as the percentage of days completed using the CUE1 device and duration of using the CUE1 device. These will be reported at each follow up appointment at weeks -3, -6 and -9. | 1 minute | |
Primary | Dropout rate | This is a feasibility outcome which will report the dropout rate at each follow up appointment at weeks -3, -6 and -9. | 1 minute | |
Primary | Physical observation | This is a safety and tolerability outcome which will be assessed by carrying out a physical observation by research team during the face to face appointments of any adverse event occurring as a result of using the adhesive patches. The adverse events in relation to the CUE1 device will be reported in the participants' clinical diary and discussed during the appointments with the research team. | 1 minute | |
Secondary | Patient's Global Impression of Change (PGI-C) questionnaire | There are two parts in the PGI-C questionnaire. In part one, the patient scores on a scale 0-7 (0 = no change or condition has got worse, 7 = a great deal better, and a considerable improvement that has made all the difference) the change in their activity limitations, symptoms, emotions and overall QoL related to painful conditions. In part two, the patient scores on a scale 0-10 (0 = much better, 10 = much worse), the score that matches their degree of change since beginning the specific care (here the intervention with CUE1). The PGI-C will be completed at follow up appointments, at weeks-3, -6, and -9. | 5 minutes | |
Secondary | Participant's clinical diary | This will be completed daily by the participant at home for 9 weeks, starting from week-1 of and finishing at the end of week-9 of the intervention. The diaries will be completed on the weeks of the intervention (e.g., 1-2, 4-5 and 7-8). The research team will provide the same instructions on how to complete the participant's diary to each person during the baseline appointment at week-0. | 15 minutes | |
Secondary | Functional Gait Assessment (FGA) | The FGA is a 10-item test that assesses performance on complex gait tasks (i.e., walking with head turns, stepping over an obstacle, stopping and turning or climbing stairs). Scores for each item are between 0-3. The highest score is 30 and greater outcomes are indicative of better performance. The FGA has been validated in healthy people, older adults with a history of falls and balance impairments, and people with balance problems including those with PD. The minimal detectable change for the FGA is reported to be 4 points in people with PD. Scores =22/30 identify fall risk and are predictable of falls in community-living older persons within 6 months. In people with PD, the cutoff point for predicting falls is 18/30, with sensitivity of 80.6%, specificity of 80.0%, and positive likelihood ratio of 4.03. | 10 minutes | |
Secondary | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Motor Part III | The MDS-UPDRS Motor Part III assesses the motor symptoms in people with PD. There are 33 scores based on 18 questions with several right, left or other body distribution scores. All items have 5 response options with uniform anchors of 0 = normal, 1 = slight (symptoms/signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/signs of frequency or intensity sufficient to cause a modest impact on function), 3 = moderate (symptoms/signs sufficiently frequent or intense to impact considerably, but not prevent function), and 4 = severe (symptoms/signs that prevent function). Higher scores indicate greater impact of PD symptoms. Score range between 0 and 132, 32 and below is mild, 59 and above is severe. | 10 minutes | |
Secondary | Timed Up and Go test (TUG) | The TUG assesses mobility, balance, walking ability, and fall risks. The mean time in people with PD has been reported between 10.3-14.8 seconds. | 5 minutes | |
Secondary | Bradykinesia Akinesia Incoordination test (BRAIN test) | The BRAIN test is used to assess upper limb motor function. The BRAIN test has been redeveloped to run in all internet browser software and has been validated in patients with PD and controls. Participants use the index finger of a single hand to alternately strike the 'S' and ';' keys on a standard computer keyboard, as fast and accurately as possible. The test is repeated for the other hand. The BRAIN test can be accessed at http://www.predictpd.com/braintest and applications to use this can be directed to AJN via the same web link. | 5 minutes | |
Secondary | Distal Finger Tapping (DFT) | The DFT test is a web-based keyboard tapping test which has been validated to remotely evaluate upper limb movements and quantify separate kinetic components such as speed, akinesia and rhythm as part of motor dysfunction in PD. It is available online via https://predictpd.com/en/braintest, and compatible with regular laptops and computers with a keyboard. The DFT test consists of a 20-second single key tapping test. Participants will be instructed to repeatedly tap the down arrow key with their left index finger, as fast as possible for 20 s, whilst simultaneously depressing the left arrow key with their left middle finger. The same task will then be repeated for the right hand. These instructions stabilise the wrist and forearm, isolating movement to the index finger metacarpal joint, thereby giving a true measurement of distal finger movement. | 5 minutes | |
Secondary | Activity-specific Balance Confidence (ABC) | The ABC is a 16-item questionnaire which assesses self-perceived balance confidence in daily activities. Scores range from 0-100; scores = 67/100 are associated with increased fall risk. Higher scores indicate greater balance confidence. | 5 minutes | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | The PSQI includes seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction. Scores range from 0-21 with a higher total score indicating worse sleep quality. In distinguishing good and poor sleepers, a global PSQI score > 5 yields sensitivity of 89.6% and specificity of 86.5%. | 5 minutes | |
Secondary | Fatigue Severity Scale (FSS) | The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders, including those with PD diagnosis. The items are scored on a 7-point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. | 5 minutes | |
Secondary | Parkinson's Disease Questionnaire (PDQ-39) | The PDQ-39 is a 39-item self-report questionnaire, which assesses PD-specific health related quality over the last month. It assesses how often patients experience difficulties across the 8 quality of life dimensions and impact of PD on specific dimensions of functioning and well-being. The scoring is done on a 5-point ordinal system (e.g., 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always). Each dimension's total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life. | 5 minutes | |
Secondary | Movement Disorder Society-Non-Motor Scale (MDS-NMS) | The MDS-NMS is a revision of the Non-Motor Symptoms Scale (NMSS) and was developed to improve and refine the assessment of non-motor symptoms in people with PD. This rater-completed assessment measures frequency and severity of 13 non-motor domains, over 52 items and covers a range of key non-motor symptoms both PD and treatment related, and in greater depth, compared with the NMSS. The scale also has a new MDS-NMS Non-Motor Fluctuations (NMF) Subscale to assess changes in non-motor symptoms in relation to the timing of anti-parkinsonian medications across 8 domains. The scoring is done on a scale 0-4 for frequency/duration and severity of symptoms (e.g., 0 absence to 4 most severe/frequent). Total score ranges between o-334, the greater the score, the more severe and frequent the non-motor symptoms experienced. | 5 minutes | |
Secondary | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I, II, IV). | The rest of the MDS-UPDRS scale consists of three parts (apart from Part III Motor which will be completed already above): Part I, II and IV which include questions to assess non-motor experiences of daily living, motor experiences of daily living, and motor complications, of people living with PD, respectively. | 15 minutes | |
Secondary | Participant's satisfaction form | This form will be will be provided to participants to complete at the last follow up appointment (week -9) to feedback on their experience on using the intervention, and support and services received from the research team. | 5 minutes |
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