Parkinson DiseaseRESPEECH-PDNCT05182892
REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
A study testing Change of stimulation amplitudes in dopaminergic OFF drug state in people with Parkinson Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Change of stimulation amplitudes in dopaminergic OFF drug state
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Dec 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Czechia1 site
- Active, not recruiting
Czech Technical University Prague
Prague, 166 27
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Inselspital, Berne
Bern, 3010
Paul Krack, Prof., 31 632 21 68 ext. +41, paul.krack@insel.ch
Mario Sousa, MD, 31 664 23 49 ext. +41, mario.sousa@insel.ch
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Change of stimulation amplitudes in dopaminergic OFF drug state
- Keywords
- Deep brain stimulation, Speech, Dysarthria, Automated speech analysis
- Medical subject headings
- Parkinson Disease, Speech, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of stimulation amplitudes in dopaminergic OFF drug stateOther
Change of stimulation amplitudes during experiment in dopaminergic OFF drug state.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: All participants | Experimental | All participants who will participate in part 1. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At visit 2 (6-12 weeks after visit 1)
Secondary outcomes (6)
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).
Measured: At visit 1 (baseline visit) and visit 2 (≤4 weeks)
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).
Measured: At visit 1 (baseline visit) and visit 2 (≤4 weeks)
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).
Measured: At visit 1 (baseline visit) and visit 2 (≤4 weeks)
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.
Measured: 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
Assessment of Parkinsonism using the full Movement Disorders Society-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III).
Measured: At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)
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.
Measured: At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start13 Dec 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (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.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Technical University in Prague
- Responsible party
- Sponsor
- Investigators
- Paul Krack, Prof., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182892
- Sponsor's protocol ID
- 2021-01787
- Acronym
- RESPEECH-PD
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REducing SPEECH-related Side-effects of Deep Brain Stimulation in Parkinson's Disease Via Automated Speech Analysis
- ClinicalTrials.gov ID
- NCT05182892
- Acronym / sponsor ID
- RESPEECH-PD / 2021-01787
- Conditions
- Parkinson Disease
- Keywords
- Deep brain stimulation, Speech, Dysarthria, Automated speech analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Czech Technical University in Prague
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 10 Jan 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: All participants | Experimental | Other: Change of stimulation amplitudes in dopaminergic OFF drug stateAll participants who will participate in part 1. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Change of stimulation amplitudes in dopaminergic OFF drug stateChange of stimulation amplitudes during experiment in dopaminergic OFF drug state. | Other | Part 1: All participants |
Primary outcome
Part 1: Identification of the most sensitive and specific speech variables
Time frame: At visit 1 (baseline visit)
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
Time frame: At visit 2 (≤4 weeks after visit 1)
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
Time frame: 12 months
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
Time frame: 12 months
Investigation of spatial overlap of VTA and the dorsolateral (sensorimotor) STN in relation to improvement of PD-related dysarthria.
Part 3: Perceptual speech ratings
Time frame: At baseline visit
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
Time frame: At visit 1 (0-6 weeks after baseline)
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
Time frame: At visit 2 (6-12 weeks after visit 1)
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
Time frame: At baseline visit
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
Time frame: At visit 1 (0-6 weeks after baseline)
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
Time frame: At visit 2 (6-12 weeks after visit 1)
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.
6 secondary outcomes
Part 1: Subjective rating of the quality of speech
Time frame: At visit 1 (baseline visit) and visit 2 (≤4 weeks)
Part 1: Assessment parkinsonism contralateral to the tested DBS lead
Time frame: At visit 1 (baseline visit) and visit 2 (≤4 weeks)
Part 1: Clinical assessment of possible side effects
Time frame: At visit 1 (baseline visit) and visit 2 (≤4 weeks)
Part 3: Subjective rating of the quality of speech
Time frame: 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
Time frame: At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)
Part 3: Clinical assessment of possible side effects
Time frame: At baseline visit, visit 1 (0-6 weeks after baseline) and visit 2 (6-12 weeks after visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Paul Krack, Prof. principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change of stimulation amplitudes in dopaminergic OFF drug state in people with Parkinson Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Switzerland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Krack, Prof. (31 632 21 68 ext. +41, paul.krack@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Identification of the most sensitive and specific speech variables (time frame: At visit 1 (baseline visit)). The study lists 10 primary outcomes in all. 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 9 Apr 2025.