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Parkinson DiseaseNCT06561919

STIMPulseControl Ancillary Speech Study

A study testing bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper in people with Parkinson Disease and Impulse Control Disorder, run by Steffen Paschen at 13 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Speech assessment is a substudy to the STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Parkinson Disease, Impulse Control Disorder
What is being tested?
bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
13 sitesin 3 countries
Study dates
5 Sep 2024to 15 Jul 2028
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Please refer to main study (STIMPulseControl KKS-313)

Who cannot join

  • Please refer to main study (STIMPulseControl KKS-313)

Trial locations and contacts

13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Steffen Paschen, MD contact

0049 431 500 23819

steffen.paschen@uksh.de

Günter Deuschl, Prof. Dr. contact

0049 431 500 238956

g.deuschl@neurologie.uni-kiel.de

13 sites in 3 countries

Germany10 sites, 10 recruiting

  • University Hospital Cologne

    Cologne

    Michael Barbe, MD

    Recruiting

  • University Hospital Carl Gustav Carus

    Dresden

    Bjoern Falkenburger, Prof.

    Recruiting

  • University Hospital Duesseldorf

    Düsseldorf

    Alfons Schnitzler, Prof.

    Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Monika Poetter-Nerger, MD

    Recruiting

  • Paracelsus - Elena- Klinik

    Kassel

    Clemens Jaksch, MD

    Clemens Jaksch, MD

    Not yet recruiting

  • University Hospital Schleswig-Holstein (UKSH), Campus Kiel

    Kiel

    Steffen Paschen, MD

    Recruiting

  • University Hospital of Giessen and Marburg (UKGM), Campus Marburg

    Marburg

    David Pedrosa, MD

    Recruiting

  • Charité Campus Mitte

    Mitte

    Patricia Krause, MD

    Recruiting

  • University Hospital Tuebingen

    Tübingen

    Daniel Weiss, Prof.

    Recruiting

  • University Hospital Wuerzburg

    Würzburg

    Jens Volkmann, Prof.

    Recruiting

Other trials in Germany

Switzerland2 sites, 2 recruiting

  • University Hospital of Bern (Inselspital)

    Bern

    Ines Debove, MD

    Paul Krack, Prof.

    Recruiting

  • University Hospital Zuerich (USZ)

    Zurich

    Lennart Stieglitz, Prof.

    Fabian Buechele, MD

    Recruiting

Other trials in Switzerland

Netherlands1 site, 1 recruiting

  • Amsterdam University Medical Center

    Amsterdam

    Rob MA De Bie, Prof.

    Annabel von der Weide, MD

    Recruiting

Other trials in Netherlands

About this study

Speech assessment is a substudy to the STIMPulseControl study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study.

Read the detailed description

Speech of all study patients enrolled in the STIMPulseControl main study will be recorded at three points of time in a standardized way. Following this ancillary protocol, patients speech will be recorded at the baseline visit (preoperatively), at the 6-months visit and at the 12-months visit postoperatively.

For the baseline speech assessment the same protocol will be performed in chronic medication conditions. At 12-month follow up, we will repeat the speech protocol in chronic medication and stimulation condition. The recordings will be done in each centre in a decentralized way and the audio files will be produced according to a standardized protocol, and assisted by a step-by-step guided speech recording software.

Main aims and hypothesis for automated speech analysis study are safety measures for surgical interventions in PD assessment of parkinsonian (hypokinetic) motor speech features outcome after STN-DBS, assessment of dyskinetic (hyperkinetic) motor speech features outcome after STN-DBS, assessment of capsular speech features outcome after STN-DBS in PD emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD assessment of acoustic and linguistic speech features as proxy for behaviour and cognitive changes in PD, comparison of emotional and cognitive speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone.

Being tested
bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper, best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper
Keywords
Speech
Medical subject headings
Parkinson Disease, Disruptive, Impulse Control, and Conduct Disorders, Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paperProcedure or surgery

    Also called best medical treatment for manangement of impulse control in Parkinson´s disease

    Best medical treatment according to widely accepted expert consensus Paper

  • best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paperDrug

    Best medical treatment according to widely accepted consensus Paper

Study groups in NCT06561919
Study groupRoleWhat they receive
DBS-groupOtherWithin indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic necleus combined with best medical treatment
Receives: Procedure: bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper
BMT-groupOtherWithin indication and clinical routine: best medical treatment
Receives: Drug: best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS

    primary aim: To globally assess motor speech features of PD change after STN-DBS intervention.

    Outcome: A compound score resulting from the normalized average of the main speech domains of hypokinetic dysarthria (i.e.phonation, articulation, prosody and timing) will be analyzed.

    For example, as proxy of phonation/voice quality, harmonics-to-noise ratio will be used. For the assessment of articulation changes, voice to onset (VOT) and Resonant frequency attenuation (RFA) will be assessed. Monopitch, will be assessed using the standard deviation of fundamental frequency (sdF0), while reduced intensity of speech variability or monoloudness will be assessed using the standard deviation of speech intensity (sdInt). To assess timing abnormalities seen in PD, prolonged pauses (PrLP), disrupting natural rhythm of speech, will be used.

    Measured: 12 months

  2. Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD

    primary aim: To assess how paralinguistic speech content changes after STN-DBS intervention.

    Outcome: A compound score resulting from the normalized average of the main emotional paralinguistic features (such as pitch variability; duration of voiced segments, pause durations and intensity variability).

    Measured: 12 months

  3. Titel PART 2: Assessment of acoustic and linguistic speech features as proxy for behavior and cognitive changes in PD

    primary aim: To assess how semantic speech content changes after STN-DBS intervention.

    Outcome: A compound score resulting from the normalized average of the main semantic features (such as content density, N-grams parameter, or moving-average type-token ratio).

    Measured: 12 months

Secondary outcomes (4)

  1. PART I/B: Safety measures for surgical interventions in PD

    secondary aim B: Comparison of paralinguistic speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone.

    Outcome: Comparison of the rate of change of the compound score resulting from the normalized average of the main semantic features (such as content density, N-grams parameter, or moving-average type-token ratio).

    Measured: 12 months

  2. PART I/B: Safety measures for surgical interventions in PD

    secondary aim B: Comparison of semantic speech outcomes before and 1-year after STN-DBS + BMT vs BMT alone.

    Outcome: Comparison of the rate of change of the compound score resulting from the normalized average of the main semantic features (such as content density, N-grams parameter, or moving-average type-token ratio).

    Measured: 12 months

  3. PART II/C: Emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in PD

    secondary aim C: Assessment of capsular speech features outcome after STN-DBS in PD.

    Outcome: A compound score resulting from the normalized average of the main speech features affected by capsular stimulation induced side-effects (such as net speech rate and pitch breaks during sustained phonation).

    Measured: 12 months

  4. PART I/A: Safety measures for surgical interventions in PD

    secondary aim A: Assessment of dyskinetic (hyperkinetic) motor speech features outcome after STN-DBS.

    Outcome: A compound score resulting from the normalized average of the main speech features affected by dyskinesia (such as intensity variability, breading capacity and spectral features variability).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start5 Sep 2024
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Jul 2028 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561919
Sponsor's protocol ID
KKS-313-A
Status last verified
Oct 2026
First submitted
24 Jun 2024
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper in people with Parkinson Disease and Impulse Control Disorder, run by Steffen Paschen at 13 sites in 3 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 1 inclusion and 1 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Switzerland, Netherlands. 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 Steffen Paschen, MD (0049 431 500 23819, steffen.paschen@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Titel: PART 1: Assessment of parkinsonian motor speech features (hypokinetic dysarthria) outcome after STN-DBS (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561919.

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 22 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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