Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients… (NCT06416553) | Clinical Trial Compass
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Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease
Czechia40 participantsStarted 2023-01-10
Plain-language summary
Up to 90% of patients with Parkinson's disease (PD) have hypokinetic dysarthria (HD) in the early phase of the illness. HD is characterized by a harsh breathy voice quality, reduced variability of pitch and loudness and imprecise articulation. This project investigates the novel combination of speech therapy and home-based non-invasive brain stimulation (tDCS) treatment in order to increase overall positive effects on HD in PD. Using a novel multimodal analysis approach based on functional magnetic resonance and acoustic signal processing, we will be able to monitor changes in different domains of speech, as well as associated changes in brain plasticity.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with clinically established PD (Postuma et al. 2016)
Exclusion Criteria:
* psychiatric disorders, including major depression, hallucinations
* any MRI-incompatible metal in the body
* epilepsy
* lack of cooperation
* presence of dementia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
Timeframe: At baseline assessment (Visit- V0), after completion of 4 weeks of intervention (stimulation+ speech therapy) (Visit V1) and 4 weeks after completion of intervention (Visit V2)