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Evaluation of Intensive Language Therapy (EILT)

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ClinicalTrials.gov Identifier: NCT02935842
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Specific SL-therapy Other: Rhythmic Balance-Movement Training (rBMT) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : September 12, 2018
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Specific SL-therapy for PD-DBS
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks
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.
Other Name: Specific, intensive and high-frequency SL-therapy

Active Comparator: Specific SL-therapy for PD non-DBS
Specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks
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.
Other Name: Specific, intensive and high-frequency SL-therapy

Active Comparator: rBMT for PD-DBS
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks
Other: 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.

Active Comparator: rBMT for PD non-DBS
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks
Other: 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.

No Intervention: PD-DBS; no therapy
No further recruiting necessary, as data is already at hand via previous research projects.
No Intervention: Healthy Controls; no therapy
No further recruiting necessary, as data is already at hand via previous research projects.



Primary Outcome Measures :
  1. Change of speech language performance across time points [ Time Frame: At Baseline (BL), (T1 only for DBS patients: within one week after DBS surgery), T2 after 4 weeks (directly after intervention), after 6 months (T3). ]
    Verbal fluency (spontaneous and directed speech), articulation and voice.


Secondary Outcome Measures :
  1. Neurophysiological health status [ Time Frame: At Baseline and at 6 Months ]
    UPDRS, medical history, questionnaires considering balance and mobility issues

  2. Neuropsychiatric self-rating questionnaires [ Time Frame: At Baseline and at 6 Months ]
  3. Neuropsychological standardised test battery (using separate and composite z-scores) [ Time Frame: At Baseline and at 6 Months ]
    Stroop, Mosaic, Trail Making, etc.

  4. Near Infrared Spectroscopy (NIRS) [ Time Frame: At Baseline (BL), (T1 only for DBS patients: within one week after DBS surgery), T2 after 4 weeks (directly after intervention), after 6 months (T3). ]
    blood exchange rate and time intervals of oxygenated blood in fronto-temporal and occipital brain areas

  5. quantitative Electroencephalography (qEEG) [ Time Frame: At Baseline and at 6 Months ]
    Production of different frequencies in specific brain areas

  6. Eye-Tracking [ Time Frame: At Baseline (BL), (T1 only for DBS patients: within one week after DBS surgery), T2 after 4 weeks (directly after intervention), after 6 months (T3). ]
    Eye-Movements (fixations, saccades and smooth pursuit) within reading comprehension and complex language comprehension paradigms



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935842


Locations
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Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Peter Fuhr, Prof.Dr.med. University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02935842     History of Changes
Other Study ID Numbers: EILT
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Possible only on an individual basis, i.e. if participant himself wishes to see score sheet for further therapy (after completion of the study and only for further therapeutic interventions independent of this study)
Keywords provided by University Hospital, Basel, Switzerland:
Parkinson's Disease
Word Retrieval
Apraxia Symptoms
Dysarthria
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases