STIMPulseControl Ancillary Speech Study

Steffen Paschen

Status: Enrolling

Conditions: Impulse Control Disorder; Parkinson Disease

Treatments: Procedure: bilateral high frequency deep brain stimulation of the subthalamic neucleus combined with best medical treatment according to widely accepted expert consensus paper; Drug: best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper

Study type: Interventional

Funder types: Other

Identifiers

NCT06561919

KKS-313-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Please refer to main study (STIMPulseControl KKS-313)

Exclusion criteria

Please refer to main study (STIMPulseControl KKS-313)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DBS-group

Other group

Description:

Within indication and clinical routine: bilateral high frequency deep brain stimulation of the subthalamic necleus combined with best medical treatment

Treatment:

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

BMT-group

Other group

Description:

Within indication and clinical routine: best medical treatment

Treatment:

Drug: best medical treatment for management of impulse control in Parkinson´s disease according to widely accepted expert consensus paper