SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease
NCT05765110, Not applicable, Recruiting, Insel Gruppe AG, University Hospital Bern
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | SPEECH as Biomarker for Emotion, Movement and cOgnition in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT05765110 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern | ClinicalTrials.gov |
| Conditions | Parkinson Disease | ClinicalTrials.gov |
| Interventions | Dopaminergic OFF drug state, DBS OFF state, Dopaminergic ON drug state, DBS ON state | ClinicalTrials.gov |
| First posted | 2023-03-13 | ClinicalTrials.gov |
| Last updated | 2026-05-22 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Part I: Changes from baseline in best acoustic speech variables to detect changes of dopaminergic and stimulation motor effect in Parkinson's disease patients | Visit 2 (< 3 months) | A speech analyser software will allow extraction of basic motor acoustic speech features. The extracted variables that better index the dopaminergic medication or stimulation motor effect assessed with Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - motor score \[0-132 pts.\] will be used as primary outcomes in this part. Higher scores in MDS-UPDRS part III means more severe motor symptoms. | ClinicalTrials.gov |
| Primary | Part II: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation neuropsychological effect in Parkinson's disease patients | Visit 2 (< 3 months) | A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation emotional effect assessed with Neuropsychiatric fluctuations scale (NFS) \[0-60 pts.\] will be used as primary outcomes in this part. Higher scores in NFS means more severe neuropsychiatric fluctuations. | ClinicalTrials.gov |
| Primary | Part III: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation cognitive effect in Parkinson's disease patients | Visit 2 (< 3 months) | A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation cognitive effect assessed with verbal fluency task will be used as primary outcomes in this part. Higher scores in Fluency task means better outcome. | ClinicalTrials.gov |
| Primary | Part III: Changes from baseline in best acoustic and linguistic speech variables to detect changes of dopaminergic and stimulation cognitive effect in Parkinson's disease patients | Visit 2 (< 3 months) | A speech analyser software will allow extraction of basic acoustic speech features. For the linguistic domain several natural language variables will be extracted covering domains such as linguistic sense, coherence, and emotionality. The extracted variables that better index the dopaminergic medication or stimulation cognitive effect assessed with Stroop test will be used as primary outcomes in this part. Higher scores in Stroop test means worse outcome. | ClinicalTrials.gov |
| Secondary | Dyskinesia severity | At visit 1 (baseline) and visit 2 (< 3 months) | Score on Marconi dyskinesia rating scale \[0-28 pts.\]. Higher scores in Marconi dyskinesia rating scale means more severe dyskinesia. | ClinicalTrials.gov |
| Secondary | Momentary mood state | At visit 1 (baseline) and visit 2 (< 3 months) | Score on Visual Analogue Mood Scale (VAMS) \[0-100 pts.\]. Higher scores in VAMS means better mood. | ClinicalTrials.gov |
| Secondary | Momentary anxiety state | At visit 1 (baseline) and visit 2 (< 3 months) | Score on Visual Analogue Anxiety Scale (VAAS) \[0-100 pts.\]. Higher scores in VAAS means more anxiety. | ClinicalTrials.gov |
| Secondary | Bradyphrenia assessment | At visit 1 (baseline) and visit 2 (< 3 months) | Score on Bradyphrenia scale \[0-72 pts.\]. Higher scores in Bradyphrenia scale means more severe bradyphrenia. | ClinicalTrials.gov |
| Other | Severity of non-motor aspects of experiences of Daily Living | < 2 weeks from the baseline visit | Score on MDS-UPDRS parts I \[0-52 pts.\]. Higher scores in MDS-UPDRS-part I scale means more severe non-motor symptoms on experiences of Daily Living | ClinicalTrials.gov |
| Other | Severity of motor aspects of experiences of Daily Living | < 2 weeks from the baseline visit | Score on MDS-UPDRS parts II \[0-52 pts.\].Higher scores in MDS-UPDRS-part II scale means more severe motor symptoms on experiences of Daily Living | ClinicalTrials.gov |
| Other | Severity of motor fluctuations | < 2 weeks from the baseline visit | Score on MDS-UPDRS parts IV \[0-24 pts.\]. Higher scores in MDS-UPDRS-part IV scale means more severe motor fluctuations | ClinicalTrials.gov |
| Other | Quality of life assessment | < 2 weeks from the baseline visit | Score on Parkinson's Disease Questionnaire, 8 items (PDQ-8) \[0-32 pts.\]. Higher scores in PDQ-8 scale means worse quality of life | ClinicalTrials.gov |
| Other | Dysarthria severity assessment | < 2 weeks from the baseline visit | Score on Voice Handicap Index (VHI) \[0-120 pts.\]. Higher scores in VHI scale means more severe dysarthria (speech impairment) | ClinicalTrials.gov |
| Other | Anxiety and depressive symptomatology | < 2 weeks from the baseline visit | Score on Hospital Anxiety and Depression Scale (HADS) \[0-60 pts.\]. Higher scores in HADS scale means more severe anxiety and depressive symptoms | ClinicalTrials.gov |
| Other | Apathetic symptomatology | < 2 weeks from the baseline visit | Score on Starkstein Apathy Scale (SAS) \[0-42 pts.\]. Higher scores in SAS scale means more severe apathetic symptoms | ClinicalTrials.gov |
| Other | Impulse-control disorders assessment | < 2 weeks from the baseline visit | Score on Questionnaire for impulsive-compulsive disorders in Parkinson's Disease-Rating Scale (QUIP-RS) \[0-112 pts.\]. Higher scores in QUIP-RS scale means more severe impulsive-compulsive disorders | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)