search
Back to results

Evaluation of Intensive Language Therapy (EILT)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Specific SL-therapy
Rhythmic Balance-Movement Training (rBMT)
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Word Retrieval, Apraxia Symptoms, Dysarthria

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

Specific SL-therapy for PD (with and without DBS)

rBMT for PD (with and without DBS)

PD (with and without DBS); no therapy

Healthy Controls; no therapy

Arm Description

Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks

Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks

No further recruiting necessary, as data is already at hand via previous research projects.

No further recruiting necessary, as data is already at hand via previous research projects.

Outcomes

Primary Outcome Measures

Velocity in Gait
Gait Velocity: meters per second
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.
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.
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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
August 18, 2016
Last Updated
May 18, 2020
Sponsor
University Hospital, Basel, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT02935842
Brief Title
Evaluation of Intensive Language Therapy
Acronym
EILT
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Word Retrieval, Apraxia Symptoms, Dysarthria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specific SL-therapy for PD (with and without DBS)
Arm Type
Experimental
Arm Description
Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks
Arm Title
rBMT for PD (with and without DBS)
Arm Type
Active Comparator
Arm Description
Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks
Arm Title
PD (with and without DBS); no therapy
Arm Type
No Intervention
Arm Description
No further recruiting necessary, as data is already at hand via previous research projects.
Arm Title
Healthy Controls; no therapy
Arm Type
No Intervention
Arm Description
No further recruiting necessary, as data is already at hand via previous research projects.
Intervention Type
Other
Intervention Name(s)
Specific SL-therapy
Other Intervention Name(s)
Specific, intensive and high-frequency SL-therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rhythmic Balance-Movement Training (rBMT)
Intervention Description
Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
Primary Outcome Measure Information:
Title
Velocity in Gait
Description
Gait Velocity: meters per second
Time Frame
At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).
Title
Cadence in Gait
Description
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.
Time Frame
At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).
Title
Speech Velocity
Description
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.
Time Frame
At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).
Title
Speech Cadence
Description
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.
Time Frame
At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).
Secondary Outcome Measure Information:
Title
Health Status (UPDRS)
Description
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.
Time Frame
At Baseline and 6 Months
Title
Neuropsychiatric Self-rating Questionnaires
Description
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.
Time Frame
At 4 Weeks and 6 Months
Title
Neuropsychological Standardised Test Battery
Description
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
Time Frame
At 4 Weeks and at 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Fuhr, Prof.Dr.med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34808624
Citation
Roesch AD, Gschwandtner U, Handabaka I, Meyer A, Taub E, Fuhr P. Effects of Rhythmic Interventions on Cognitive Abilities in Parkinson's Disease. Dement Geriatr Cogn Disord. 2021;50(4):372-386. doi: 10.1159/000519122. Epub 2021 Oct 28.
Results Reference
derived

Learn more about this trial

Evaluation of Intensive Language Therapy

We'll reach out to this number within 24 hrs