An interventional study of Home-based transcranial direct current stimulation- real tDCS and Home-based transcranial direct current stimulation- sham tDCS in Parkinson Disease, sponsored by Masaryk University. Status unknown at 1 site in Czechia. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Masaryk University · Not applicable, Interventional, and Treatment
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.
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.
4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Masaryk University is the lead sponsor of 45 studies on the registry; 20 are open to participants now.
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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.
Device: Home-based transcranial direct current stimulation- real tDCS · Behavioral: Lee-Silverman voice treatment
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.
Device: Home-based transcranial direct current stimulation- sham tDCS · Behavioral: Lee-Silverman voice treatment
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- anode over right STG, cathode over left STG, sham stimulation with tDCS mini-CT device by Soterix Medical
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.
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.
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)
Resting state fMRI
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
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)
Started Jan 2023 (actual). Primary completion is estimated for Nov 2025, 34 months after the start.
Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 34 months is above that.
Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Masaryk University