Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561919
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
STIMPulseControl Ancillary Speech Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
STIMPulseControl Ancillary Speech Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None