N/A
N=20
Evaluation of Intensive Language Therapy
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02935842 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Velocity in Gait — 1.2; 1.2; 1.2; .8 meter per second — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Specific SL-therapy (Other); Rhythmic Balance-Movement Training (rBMT) (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University Hospital, Basel, Switzerland
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Velocity in Gait |
1.2; 1.2; 1.2; .8; 1.3; 1.2 | .05 |
| PRIMARY Cadence in Gait |
2.5; 2.5; 2.7; 1.7; 2.8; 2.7 | — |
| PRIMARY Speech Velocity |
3.6; 4.2; 4.9; 2.3; 3.8; 4.8 | — |
| PRIMARY Speech Cadence |
15.6; 13.1; 10.9; 21.6; 13.3; 13.6 | — |
| SECONDARY Health Status (UPDRS) |
38.6; 37.3; 42.8; 0; 35.6; 41.7 | .05 |
| SECONDARY Neuropsychiatric Self-rating Questionnaires |
8; 7.6; 7.1; 5.5; 7.4; 8.8 | — |
| SECONDARY Neuropsychological Standardised Test Battery |
-.9; -.3; -.7; -.4; -.7; -.6 | .05 |
Summary
Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the literature reports that PD patients, who have not undergone deep brain stimulation (DBS), have deficits regarding voice quality (e.g. loudness and intelligibility of their voice), while PD patients who have undergone DBS suffer from deficits in word retrieval and speech apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated.
Therefore, this study investigates the short-and longterm effectiveness of specific and intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training (rBMT)) as well as to a 'no-therapy' condition.
Eligibility Criteria
Inclusion Criteria for all groups:
- The patient is able to cooperate
- The patient has the mental competence to provide informed consent to participate in the study
- The patient speaks and understands German
Specific Inclusion Criteria for the DBS Group
- Fulfilling the above stated inclusion criteria as stated in a, b and c above
- The patient is responsive to Levodopa (L-DOPA)
- Having received or being scheduled for DBS
Exclusion Criteria
- Severe psychiatric disease difficult to treat (compulsive disorder, depression, mania, psychosis, anxiety as outlined in International Classification of Diseases (ICD-10) (WHO 2015, current version).
- Patient with dementia (DMS-V, Mini-Mental-Status-Test (MMS) <24, Montreal Cognitive Assessment (MoCa) <21)
- Secondary Parkinsonism
- Age ≤18 years
- Pregnancy (early onset)
- Presence of a known disease other than PD that shortens the life expectancy
- Mental incompetence to provide informed consent to participate in the study
- Previous intracranial surgery
- Epilepsy
- Contraindications for DBS seen in MRI-scan (malignant tumour, severe microvascular disease)
- Insufficient skills of German language for participating in neuropsychological evaluations
- Sensory problems, severe enough to significantly interfere with neuropsychological assessment
- Alcohol and/or drug addiction
Data sourced from ClinicalTrials.gov (NCT02935842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.