Evaluation of Intensive Language Therapy

Not Applicable

Completed

Interventions: Other: Specific SL-therapy
Other: Rhythmic Balance-Movement Training (rBMT)

Brief 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.

Detailed Description: In the course of Parkinson's disease (PD) speech and language (SL) deficits may often emerge. In addition, severe verbal fluency (VF) decline has been repeatedly observed in the context of deep brain stimulation (DBS) in PD. Interestingly, while PD non-DBS patients have deficits with respect to loudness and intelligibility of their voice, PD patients who have undergone DBS (PD-DBS) suffer rather from difficulties in semantic and phonemic word retrieval, and from speech apraxia symptoms.

However, to-date and to the best of our knowledge, therapeutic approaches focusing specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated regarding their effectiveness. Thus, 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

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

Arm && Interventions

Group	Intervention	Description
Specific SL-therapy for PD (with and without DBS)	Rhythmic Balance-Movement Training (rBMT)	Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks
Specific SL-therapy for PD (with and without DBS)	Specific SL-therapy	Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks
rBMT for PD (with and without DBS)	Rhythmic Balance-Movement Training (rBMT)	Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks
rBMT for PD (with and without DBS)	Specific SL-therapy	Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks

Primary Outcome Measures

Name	Time	Method
Speech Cadence	At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).	Speech Cadence 4 Weeks and at 6 Months To measure rhythmicity in speech, participants' speech was recorded while reading a text aloud ('the north wind and the sun'). Elicited syllables per inspiration were analysed.
Velocity in Gait	At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).	Gait Velocity: meters per second
Cadence in Gait	At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).	4-Weeks and 6-Months Follow-up. To measure rhythmicity in gait, participants walked 6 metres at their individual pace. They were timed and amount of steps were counted.
Speech Velocity	At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).	Speech Velocity at 4 weeks and at 6 months To measure rhythmicity in speech, participants read a text aloud ('the north wind and the sun') and were recorded using an Olympus. According to these speech samples, the count of elicited syllables per second was calculated.

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Self-rating Questionnaires	At 4 Weeks and 6 Months	Self-rating questionnaires investigating depression using the Beck's Depression Inventory (BDI). This is a 21 question, multiple choice, self-report questionnaire. Minimum score is 0 and maximum scores is 63. The higher the score the more severe is the depression. Details: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Health Status (UPDRS)	At Baseline and 6 Months	The complete questionnaire 'Unified Parkinson's Disease Rating Scale' (UPDRS) was filled out at BL and 6M. Scores may range from 0-4 per question. Final scores may add up to 199 points maximum. The higher the score, the worse disease severity/ degree of disability is.
Neuropsychological Standardised Test Battery	At 4 Weeks and at 6 Months	Inhibition Control (Stroop), Visio-Construction (Mosaic), Flexibility (Trail Making Test), Episodic Memory (Basel Verbal Learning Test -long delayed free recall), Working Memory (backwards digit span task by Wechsler). Scores were standardized (z-scores) to a mean of 0 and standard deviation of 1. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population