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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935842
Other study ID # EILT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date October 24, 2018

Study information

Verified date May 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 38
Est. completion date October 24, 2018
Est. primary completion date September 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Specific SL-therapy
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.
Rhythmic Balance-Movement Training (rBMT)
Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.

Locations

Country Name City State
Switzerland University Hospital Basel Basel BS

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Velocity in Gait Gait Velocity: meters per second At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).
Primary 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).
Primary 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).
Primary 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 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
Secondary 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
Secondary 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
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