STIMPulseControl Ancillary Speech Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSteffen Paschen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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

    Drug

    Best medical treatment according to widely accepted consensus Paper

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: DBS-groupOther 1 intervention
Group B: BMT-groupOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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).

Time frame
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).

Time frame
12 months

Secondary outcomes

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).

Time frame
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).

Time frame
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).

Time frame
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).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Steffen Paschen

Lead sponsor

University of Kiel

Sponsor institution

Czech Technical University in Prague

Collaborator

Insel Gruppe AG, University Hospital Bern

Collaborator

Philipps University Marburg

Collaborator

University Hospital Schleswig-Holstein

Collaborator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Collaborator