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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Change of stimulation amplitudes in dopaminergic OFF drug state
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Deep brain stimulation, Speech, Dysarthria, Automated speech analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Change of parkinsonian medication in the last four weeks prior to inclusion in part 1 and 3
  • Change of STN-DBS parameters in the last four weeks prior to inclusion (for parts 1 and 3)
  • Depression with acute suicidal ideation
  • Pregnant women

Sites / Locations

  • Czech Technical University Prague
  • University Hospital Inselspital, BerneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Part 1: All participants

Part 2: All participants

Part 3: All participants

Arm Description

All participants who will participate in part 1.

All participants who participated in part 1

All participants who will participate in part 3

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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.
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.
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.

Secondary Outcome Measures

Part 1: Subjective rating of the quality of speech
Subjective rating of the quality of speech on a numeric rating scale by the patient, ranging from 0 = no impairment to 10 = maximum conceivable impairment of speech. Assessment will be performed under the two conditions (dopaminergic ON and OFF drug state).
Part 1: Assessment parkinsonism contralateral to the tested DBS lead
Assessment parkinsonism contralateral to the tested DBS lead using items 3.4 (finger tapping), 3.5 (hand movements), 3.7 (toe tapping) and 3.8 (leg agility) of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III) for the limbs contralateral to the tested DBS electrode. Assessment will be performed under the two conditions (dopaminergic ON and OFF drug state).
Part 1: Clinical assessment of possible side effects
Noting possible side effects that may occur during the experiment, such as fascial spasm or contraction of the hand muscles. Assessment will be performed under the two conditions (dopaminergic ON and OFF drug state).
Part 3: Subjective rating of the quality of speech
Subjective rating of the quality of speech on a numeric rating scale by the patient, ranging from 0 = no impairment to 10 = maximum conceivable impairment of speech.
Part 3: Assessment of motoric symptoms
Assessment of Parkinsonism using the full Movement Disorders Society-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III).
Part 3: Clinical assessment of possible side effects
Noting possible side effects that may occur during the experiment, such as fascial spasm or contraction of the hand muscles.

Full Information

First Posted
December 22, 2021
Last Updated
January 11, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05182892
Brief Title
REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
Acronym
RESPEECH-PD
Official Title
REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an effective treatment of L-dopa sensitive motor symptoms of Parkinson's disease (PD) but its effects on speech are equivocal. Although some aspects of speech might improve with STN-DBS, stimulation-induced dysarthria represents one of the most common side effects, with a prevalence of up to 90%. Worsening of speech can neutralize the motor benefits of STN-DBS in terms of overall benefit in quality of life. STN-DBS induced dysarthria is not understood in sufficient detail that would allow its prevention or sustained reduction. The human ear is too limited in quantifying subtle changes in speech and to differentiate between parkinsonian and stimulation induced dysarthria. 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. In Part 1, the investigators' aim is to identify the most sensitive and specific speech variables for STN-DBS-related improvement of parkinsonian dysarthria and STN-DBS-induced speech-related side-effects, by application of an automated acoustic speech analysis technique. Patients with STN-DSB induced dysarthria will be examined in their medication ON state. Where possible the study will also be performed in the medication OFF state (after an overnight withdrawal of their PD medication). In both states, speech analysis will be performed in the stimulation OFF and ON states, as well as with increasing stimulation amplitudes. In Part 2, the investigators' aim at investigating the anatomical and pathophysiological substrates of STN-DBS induced changes in speech production, by establishing stimulation maps. Stimulation maps highlight effective regions of stimulation and can help clinicians to navigate and program DBS steering the current towards the target region that improves speech (here a priori the sensorimotor STN for improving parkinsonian speech together with other parkinsonian signs), while avoiding current diffusion to regions identified as potentially worsening speech. Part 3 is explorative. The investigators' hypothesize, that selected speech variables in automated speech analysis (as identified in part 1+2) are more sensitive to improvement of STN-DBS induced dysarthria, than ratings of three blinded speech-therapists. Again patients with STN-DBS induced dysarthria will be recruited to this study (willing participants of part 1+2 and patients who did not participate in part 1+2 will be included). The investigators will assess dysarthria by automated speech analysis, expert ratings and subjective ratings, before (at baseline visit) and at two time points (at V1 between 0-6 weeks after baseline and at V2 between 6-12 weeks after V1) after measures are taken to reduce stimulation induced dysarthria. Measures to reduce STN-DBS induced dysarthria will include all DBS settings that are routinely applied in daily clinical practice for dysarthria reduction. DBS-settings will be performed on both DBS-leads and patients will be in the medication ON state.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep brain stimulation, Speech, Dysarthria, Automated speech analysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
Speech ratings in part 3 will be performed by speech therapists. They are blinded towards stimulator setting and visit number.
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: All participants
Arm Type
Experimental
Arm Description
All participants who will participate in part 1.
Arm Title
Part 2: All participants
Arm Type
No Intervention
Arm Description
All participants who participated in part 1
Arm Title
Part 3: All participants
Arm Type
No Intervention
Arm Description
All participants who will participate in part 3
Intervention Type
Other
Intervention Name(s)
Change of stimulation amplitudes in dopaminergic OFF drug state
Intervention Description
Change of stimulation amplitudes during experiment in dopaminergic OFF drug state.
Primary Outcome Measure Information:
Title
Part 1: Identification of the most sensitive and specific speech variables
Description
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.
Time Frame
At visit 1 (baseline visit)
Title
Part 1: Identification of the most sensitive and specific speech variables
Description
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.
Time Frame
At visit 2 (≤4 weeks after visit 1)
Title
Part 2, Speech analysis: Investigation of spatial overlap of volume of tissue activated (VTA) and the corticobulbar/corticospinal tract
Description
Investigation of spatial overlap of tissue activated (VTA) and the corticobulbar/corticospinal tract, in relation to the dysarthria-worsening.
Time Frame
12 months
Title
Part 2, Speech analysis: Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN
Description
Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN in relation to improvement of PD-related dysarthria.
Time Frame
12 months
Title
Part 3: Perceptual speech ratings
Description
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).
Time Frame
At baseline visit
Title
Part 3: Perceptual speech ratings
Description
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).
Time Frame
At visit 1 (0-6 weeks after baseline)
Title
Part 3: Perceptual speech ratings
Description
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).
Time Frame
At visit 2 (6-12 weeks after visit 1)
Title
Part 3: Automated speech analysis
Description
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.
Time Frame
At baseline visit
Title
Part 3: Automated speech analysis
Description
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.
Time Frame
At visit 1 (0-6 weeks after baseline)
Title
Part 3: Automated speech analysis
Description
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.
Time Frame
At visit 2 (6-12 weeks after visit 1)
Secondary Outcome Measure Information:
Title
Part 1: Subjective rating of the quality of speech
Description
Subjective rating of the quality of speech on a numeric rating scale by the patient, ranging from 0 = no impairment to 10 = maximum conceivable impairment of speech. Assessment will be performed under the two conditions (dopaminergic ON and OFF drug state).
Time Frame
At visit 1 (baseline visit) and visit 2 (≤4 weeks)
Title
Part 1: Assessment parkinsonism contralateral to the tested DBS lead
Description
Assessment parkinsonism contralateral to the tested DBS lead using items 3.4 (finger tapping), 3.5 (hand movements), 3.7 (toe tapping) and 3.8 (leg agility) of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III) for the limbs contralateral to the tested DBS electrode. Assessment will be performed under the two conditions (dopaminergic ON and OFF drug state).
Time Frame
At visit 1 (baseline visit) and visit 2 (≤4 weeks)
Title
Part 1: Clinical assessment of possible side effects
Description
Noting possible side effects that may occur during the experiment, such as fascial spasm or contraction of the hand muscles. Assessment will be performed under the two conditions (dopaminergic ON and OFF drug state).
Time Frame
At visit 1 (baseline visit) and visit 2 (≤4 weeks)
Title
Part 3: Subjective rating of the quality of speech
Description
Subjective rating of the quality of speech on a numeric rating scale by the patient, ranging from 0 = no impairment to 10 = maximum conceivable impairment of speech.
Time Frame
At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)
Title
Part 3: Assessment of motoric symptoms
Description
Assessment of Parkinsonism using the full Movement Disorders Society-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III).
Time Frame
At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)
Title
Part 3: Clinical assessment of possible side effects
Description
Noting possible side effects that may occur during the experiment, such as fascial spasm or contraction of the hand muscles.
Time Frame
At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Change of parkinsonian medication in the last four weeks prior to inclusion in part 1 and 3 Change of STN-DBS parameters in the last four weeks prior to inclusion (for parts 1 and 3) Depression with acute suicidal ideation Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Krack, Prof.
Phone
31 632 21 68
Ext
+41
Email
paul.krack@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Sousa, MD
Phone
31 664 23 49
Ext
+41
Email
mario.sousa@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Krack, Prof.
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Czech Technical University Prague
City
Prague
ZIP/Postal Code
166 27
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Inselspital, Berne
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Krack, Prof.
Phone
31 632 21 68
Ext
+41
Email
paul.krack@insel.ch
First Name & Middle Initial & Last Name & Degree
Mario Sousa, MD
Phone
31 664 23 49
Ext
+41
Email
mario.sousa@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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

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