Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease

NCT06416553 | Recruiting

• 1 other identifier: NU22J-04-00074
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At baseline assessment (Visit- V0), after completion of 4 weeks of intervention (stimulation+ speech therapy) (V1) and 4 weeks after completion of intervention (V2)

Study Arms (2)

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.

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.

Device: Home-based transcranial direct current stimulation- sham tDCS; Behavioral: Lee-Silverman voice treatment

Interventions

Home-based transcranial direct current stimulation- real tDCS DEVICE

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

PD patients with real tDCS and speech therapy

Home-based transcranial direct current stimulation- sham tDCS DEVICE

Home-based transcranial direct current stimulation- anode over right STG, cathode over left STG, sham stimulation with tDCS mini-CT device by Soterix Medical

PD patients with sham tDCS and speech therapy

Lee-Silverman voice treatment BEHAVIORAL

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.

PD patients with real tDCS and speech therapy; PD patients with sham tDCS and speech therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with clinically established PD (Postuma et al. 2016)

You may not qualify if:

• psychiatric disorders, including major depression, hallucinations
• any MRI-incompatible metal in the body
• epilepsy
• lack of cooperation
• presence of dementia

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

Central European Institute of Technology

Brno, Czechia

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Lubos Brabenec

CONTACT

+420731076102; lubos.brabenec@ceitec.muni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: May 16, 2024
• Study Start: January 10, 2023
• Primary Completion: November 15, 2025
• Study Completion: December 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CZ (1)