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Completed

NCT Number: NCT02935842

Evaluation of Intensive Language Therapy

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.

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Key information

Conditions

Parkinson's Disease Articulation Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Communication Disorders Dysarthria Language Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific SL-therapy

Other

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 names: Specific, intensive and high-frequency SL-therapy

Rhythmic Balance-Movement Training (rBMT)

Other

Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.

Primary outcomes

  1. Velocity in Gait

    Time frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

    Gait Velocity: meters per second

  2. Cadence in Gait

    Time frame: 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.

  3. Speech Velocity

    Time frame: 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.

  4. Speech Cadence

    Time frame: 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.

Secondary outcomes

  1. Health Status (UPDRS)

    Time frame: 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.

  2. Neuropsychiatric Self-rating Questionnaires

    Time frame: 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.

  3. Neuropsychological Standardised Test Battery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: EILT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2016
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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