Evaluation of Intensive Language Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded Trial

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Specific SL-therapy
* Other: Rhythmic Balance-Movement Training (rBMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific SL-therapy for PD (with and without DBS)<br>Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks | Other: Specific SL-therapy<br>* Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.<br>* Other names: Specific, intensive and high-frequency SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT)<br>* Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.<br>|
| Active Comparator: rBMT for PD (with and without DBS)<br>Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks | Other: Specific SL-therapy<br>* Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.<br>* Other names: Specific, intensive and high-frequency SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT)<br>* Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.<br>|
| No Intervention: PD (with and without DBS); no therapy<br>No further recruiting necessary, as data is already at hand via previous research projects. | |
| No Intervention: Healthy Controls; no therapy<br>No further recruiting necessary, as data is already at hand via previous research projects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity in Gait | Gait Velocity: meters per second | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). | 
| Cadence in Gait | 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. | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). | 
| Speech Velocity | 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. | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). | 
| Speech Cadence | 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. | At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status (UPDRS) | 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. | At Baseline and 6 Months | 
| Neuropsychiatric Self-rating Questionnaires | 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. | At 4 Weeks and 6 Months | 
| Neuropsychological Standardised Test Battery | 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 | At 4 Weeks and at 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Word Retrieval, Apraxia Symptoms, Dysarthria