REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis

NCT05182892 | Recruiting

• 1 other identifier: 2021-01787
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

Brief Summary

The investigators' objective is to improve L-dopa sensitive PD-related dysarthria and at the same time reduce DBS-induced speech disorders with the help of automated acoustic analysis in patients with STN-DBS-induced dysarthria.

Conditions

Parkinson Disease

Keywords

Deep brain stimulation; Speech; Dysarthria; Automated speech analysis

Outcome Measures

Primary Outcomes (10)

• Part 1: Identification of the most sensitive and specific speech variables

  Identification of the most sensitive and specific speech variables of an automated acoustic analysis method, for STN-DBS-related improvement as well as worsening of speech in PD patients, under the two conditions (dopaminergic ON and OFF drug state). Speech variables will be extracted from the automated acoustic analysis.

  At visit 1 (baseline visit)

• Part 1: Identification of the most sensitive and specific speech variables

  Identification of the most sensitive and specific speech variables of an automated acoustic analysis method, for STN-DBS-related improvement as well as worsening of speech in PD patients, under the two conditions (dopaminergic ON and OFF drug state). Speech variables will be extracted from the automated acoustic analysis.

  At visit 2 (≤4 weeks after visit 1)

• Part 2, Speech analysis: Investigation of spatial overlap of volume of tissue activated (VTA) and the corticobulbar/corticospinal tract

  Investigation of spatial overlap of tissue activated (VTA) and the corticobulbar/corticospinal tract, in relation to the dysarthria-worsening.

  12 months

• Part 2, Speech analysis: Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN

  Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN in relation to improvement of PD-related dysarthria.

  12 months

• Part 3: Perceptual speech ratings

  To test if the model 'perceptual speech ratings' explains subjective improvement of STN-DBS induced dysarthria. Perceptive rating will be performed by three experienced speech therapists, who will rate speech on a visual analogue scale (VAS).

  At baseline visit

• Part 3: Perceptual speech ratings

  To test if the model 'perceptual speech ratings' explains subjective improvement of STN-DBS induced dysarthria. Perceptive rating will be performed by three experienced speech therapists, who will rate speech on a visual analogue scale (VAS).

  At visit 1 (0-6 weeks after baseline)

• Part 3: Perceptual speech ratings

  To test if the model 'perceptual speech ratings' explains subjective improvement of STN-DBS induced dysarthria. Perceptive rating will be performed by three experienced speech therapists, who will rate speech on a visual analogue scale (VAS).

  At visit 2 (6-12 weeks after visit 1)

• Part 3: Automated speech analysis

  To test if the model 'automated speech analysis' explains subjective improvement of STN-DBS induced dysarthria. From the automated speech analysis, only the speech parameters explaining most of the variance in the model from part 2 will be included in the analysis.

  At baseline visit

• Part 3: Automated speech analysis

  To test if the model 'automated speech analysis' explains subjective improvement of STN-DBS induced dysarthria. From the automated speech analysis, only the speech parameters explaining most of the variance in the model from part 2 will be included in the analysis.

  At visit 1 (0-6 weeks after baseline)

• Part 3: Automated speech analysis

  To test if the model 'automated speech analysis' explains subjective improvement of STN-DBS induced dysarthria. From the automated speech analysis, only the speech parameters explaining most of the variance in the model from part 2 will be included in the analysis.

  At visit 2 (6-12 weeks after visit 1)

Secondary Outcomes (6)

• Part 1: Subjective rating of the quality of speech

  At visit 1 (baseline visit) and visit 2 (≤4 weeks)

• Part 1: Assessment parkinsonism contralateral to the tested DBS lead

  At visit 1 (baseline visit) and visit 2 (≤4 weeks)

• Part 1: Clinical assessment of possible side effects

  At visit 1 (baseline visit) and visit 2 (≤4 weeks)

• Part 3: Subjective rating of the quality of speech

  At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)

• Part 3: Assessment of motoric symptoms

  At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)

Study Arms (3)

Part 1: All participants

EXPERIMENTAL

All participants who will participate in part 1.

Other: Change of stimulation amplitudes in dopaminergic OFF drug state

Part 2: All participants

NO INTERVENTION

All participants who participated in part 1

Part 3: All participants

NO INTERVENTION

All participants who will participate in part 3

Interventions

Change of stimulation amplitudes in dopaminergic OFF drug state OTHER

Change of stimulation amplitudes during experiment in dopaminergic OFF drug state.

Part 1: All participants

Eligibility Criteria

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

You may qualify if:

• Idiopathic Parkinson-Syndrome according to the Movement Disorders Society Criteria
• Treatment with bilateral deep brain stimulation in the subthalamic nucleus (for parts 1, 2 and 3)
• Time since DBS-STN operation ≥ 3 month (for parts 1, 2 and 3)
• Able to give informed consent as documented by signature
• Fluent in Swiss-German or German
• STN-DBS-induced dysarthria. In an operational definition, all PD-patients who reported -worsening of speech time-locked to STN-DBS implantation or patients with dysarthria on chronic stimulation improving with reduction of stimulation amplitudes in the context of postoperative routine follow up will be defined as having STN-DBS-induced dysarthria

You may not qualify if:

• Dysarthria caused in addition by a condition other than PD or DBS (e.g. stroke, myasthenia)
• Clinical diagnosis of aphasia
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders and dementia. A Montreal Cognitive Assesment (MoCa) will be performed and patients with ≤ 20 of 30 points will be excluded
• Depression with acute suicidal ideation
• Pregnant women

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Czech Technical University in Prague: collaborator

Study Sites (2)

Czech Technical University Prague

Prague, 166 27, Czechia

ACTIVE NOT RECRUITING

University Hospital Inselspital, Berne

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Speech; Dysarthria

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Verbal Behavior; Communication; Behavior; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Krack, Prof.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Krack, Prof.

CONTACT

31 632 21 68; paul.krack@insel.ch

Mario Sousa, MD

CONTACT

31 664 23 49; mario.sousa@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Speech ratings in part 3 will be performed by speech therapists. They are blinded towards stimulator setting and visit number.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 10, 2022
• Study Start: December 13, 2021
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); CH (1)