Parkinson DiseaseNCT06416553
Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease
A study testing Home-based transcranial direct current stimulation- real tDCS and Lee-Silverman voice treatment in people with Parkinson Disease, run by Masaryk University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Home-based transcranial direct current stimulation- real tDCS and Lee-Silverman voice treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Jan 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with clinically established PD (Postuma et al. 2016)
Who cannot join
- psychiatric disorders, including major depression, hallucinations
- any MRI-incompatible metal in the body
- epilepsy
- lack of cooperation
- presence of dementia
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Central European Institute of Technology
Brno
Lubos Brabenec, +420731076102, lubos.brabenec@ceitec.muni.cz
About this study
Official title: Home-based Non-invasive Brain Stimulation in Combination With Lee Silverman Voice Treatment on Hypokinetic Dysarthria in Parkinson's Disease
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.
Read the detailed description
Study will investigate the long-term effects of repeated (20) sessions of home-based tDCS as an add-on to well-established remote LSVT (i.e. the gold standard procedure for HD treatment) as compared to LSVT alone (coupled with sham stimulation) in patients with PD in their "on" dopaminergic condition without dyskinesias.
A two parallel-group, double-blinded, randomized, sham-stimulation-controlled design will be used. Forty PD patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list, 20 subjects in each arm. Participants in the real tDCS group and the sham tDCS group will undergo a baseline assessment (V0), a follow-up assessment after four weeks of combined tDCS and LSVT treatments (V1) and another follow-up assessment 8 weeks after the baseline assessment (V2). Each visit will consist of EEG, speech tasks recording and speech evaluation by a speech therapist; MR scanning will be done at V0 and V1. Both groups will undergo the same speech therapy (LSVT) via telepractice as the gold standard treatment for HD, in combination with real or sham tDCS.
- Conditions
- Parkinson Disease
- Being tested
- Home-based transcranial direct current stimulation- real tDCS, Home-based transcranial direct current stimulation- sham tDCS, Lee-Silverman voice treatment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based transcranial direct current stimulation- real tDCSDevice
Home-based transcranial direct current stimulation- anode over right STG, cathode over left STG, 2 mA stimulation with 1x1 tDCS mini-CT device by Soterix Medical
Home-based transcranial direct current stimulation- sham tDCSDevice
Home-based transcranial direct current stimulation- anode over right STG, cathode over left STG, sham stimulation with tDCS mini-CT device by Soterix Medical
Lee-Silverman voice treatmentBehavioural
Remote Lee Silverman Voice Treatment (LSVT) delivered via telepractice by speech therapist. LSVT is a high-effort speech therapy that is primarily focused on improving speech loudness during 16 individual one-hour sessions in one month.
| Study group | Role | What they receive |
|---|---|---|
| PD patients with real tDCS and speech therapy | Active comparator | Patients will receive real tDCS during 4 weeks, 5 sessions per week. Altogether 20 sessions, each 20 minutes long. Stimulation is combined with Lee-Silverman voice treatment, 4 sessions per week. Altogether 16 sessions, each 1 hour long. Receives: Device: Home-based transcranial direct current stimulation- real tDCS; Behavioral: Lee-Silverman voice treatment |
| PD patients with sham tDCS and speech therapy | Sham comparator | Patients will receive sham tDCS during 4 weeks, 5 sessions per week. Altogether 20 sessions, each 20 minutes long. Stimulation is combined with Lee-Silverman voice treatment, 4 sessions per week. Altogether 16 sessions, each 1 hour long. Receives: Device: Home-based transcranial direct current stimulation- sham tDCS; Behavioral: Lee-Silverman voice treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
The 3F Test Dysarthric Profile enables clinicians to characterize a wide range of signs and symptoms of dysarthria. The minimum value of this scale is 0 (anarthria), the maximum value is 90 (no disorder). Higher scores of this scale mean better outcome. This test will be administrated by speech pathologist.
Measured: 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)
Secondary outcomes (1)
Resting state fMRI
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
Measured: At baseline assessment (Visit- V0), after completion of 4 weeks of intervention (stimulation+ speech therapy) (V1) and 4 weeks after completion of intervention (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 Jan 2023
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated for 4 weeks (20 sessions), stimulation will be combined with speech therapy . Other twenty PD patients will be stimulated with the same protocol using sham stimulation, sham stimulation will be combined with speech therapy.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416553
- Sponsor's protocol ID
- NU22J-04-00074
- Status last verified
- May 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Non-invasive Brain Stimulation in Combination With Lee Silverman Voice Treatment on Hypokinetic Dysarthria in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06416553
- Acronym / sponsor ID
- NU22J-04-00074
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study will investigate the long-term effects of repeated (20) sessions of home-based tDCS as an add-on to well-established remote LSVT (i.e. the gold standard procedure for HD treatment) as compared to LSVT alone (coupled with sham stimulation) in patients with PD in their "on" dopaminergic condition without dyskinesias.
A two parallel-group, double-blinded, randomized, sham-stimulation-controlled design will be used. Forty PD patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list, 20 subjects in each arm. Participants in the real tDCS group and the sham tDCS group will undergo a baseline assessment (V0), a follow-up assessment after four weeks of combined tDCS and LSVT treatments (V1) and another follow-up assessment 8 weeks after the baseline assessment (V2). Each visit will consist of EEG, speech tasks recording and speech evaluation by a speech therapist; MR scanning will be done at V0 and V1. Both groups will undergo the same speech therapy (LSVT) via telepractice as the gold standard treatment for HD, in combination with real or sham tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated for 4 weeks (20 sessions), stimulation will be combined with speech therapy . Other twenty PD patients will be stimulated with the same protocol using sham stimulation, sham stimulation will be combined with speech therapy.
| Arm | Type | Receives |
|---|---|---|
| PD patients with real tDCS and speech therapy | Active comparator | Device: Home-based transcranial direct current stimulation- real tDCS, Behavioral: Lee-Silverman voice treatmentPatients will receive real tDCS during 4 weeks, 5 sessions per week. Altogether 20 sessions, each 20 minutes long. Stimulation is combined with Lee-Silverman voice treatment, 4 sessions per week. Altogether 16 sessions, each 1 hour long. |
| PD patients with sham tDCS and speech therapy | Sham comparator | Device: Home-based transcranial direct current stimulation- sham tDCS, Behavioral: Lee-Silverman voice treatmentPatients will receive sham tDCS during 4 weeks, 5 sessions per week. Altogether 20 sessions, each 20 minutes long. Stimulation is combined with Lee-Silverman voice treatment, 4 sessions per week. Altogether 16 sessions, each 1 hour long. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with clinically established PD (Postuma et al. 2016)
Key exclusion criteria (5 listed)
- psychiatric disorders, including major depression, hallucinations
- any MRI-incompatible metal in the body
- epilepsy
- lack of cooperation
- presence of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based transcranial direct current stimulation- real tDCSHome-based transcranial direct current stimulation- anode over right STG, cathode over left STG, 2 mA stimulation with 1x1 tDCS mini-CT device by Soterix Medical | Device | PD patients with real tDCS and speech therapy |
| Home-based transcranial direct current stimulation- sham tDCSHome-based transcranial direct current stimulation- anode over right STG, cathode over left STG, sham stimulation with tDCS mini-CT device by Soterix Medical | Device | PD patients with sham tDCS and speech therapy |
| Lee-Silverman voice treatmentRemote Lee Silverman Voice Treatment (LSVT) delivered via telepractice by speech therapist. LSVT is a high-effort speech therapy that is primarily focused on improving speech loudness during 16 individual one-hour sessions in one month. | Behavioural | PD patients with real tDCS and speech therapy, PD patients with sham tDCS and speech therapy |
Primary outcome
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile")
Time frame: 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)
The 3F Test Dysarthric Profile enables clinicians to characterize a wide range of signs and symptoms of dysarthria. The minimum value of this scale is 0 (anarthria), the maximum value is 90 (no disorder). Higher scores of this scale mean better outcome. This test will be administrated by speech pathologist.
1 secondary outcome
Resting state fMRI
Time frame: At baseline assessment (Visit- V0), after completion of 4 weeks of intervention (stimulation+ speech therapy) (V1) and 4 weeks after completion of intervention (V2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based transcranial direct current stimulation- real tDCS and Lee-Silverman voice treatment in people with Parkinson Disease, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lubos Brabenec (+420731076102, lubos.brabenec@ceitec.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in score of the 3F Test (the unabbreviated title- "the 3F Test Dysarthric Profile") (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.