Evaluation of Intensive Language Therapy

NCT02935842 | Completed Results DMC

• 1 other identifier: EILT
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Word Retrieval; Apraxia Symptoms; Dysarthria

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Health Status (UPDRS)

  At Baseline and 6 Months

• Neuropsychiatric Self-rating Questionnaires

  At 4 Weeks and 6 Months

• Neuropsychological Standardised Test Battery

  At 4 Weeks and at 6 Months

Study Arms (4)

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

EXPERIMENTAL

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

Other: Specific SL-therapy; Other: Rhythmic Balance-Movement Training (rBMT)

rBMT for PD (with and without DBS)

ACTIVE COMPARATOR

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

Other: Specific SL-therapy; Other: Rhythmic Balance-Movement Training (rBMT)

PD (with and without DBS); no therapy

NO INTERVENTION

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

Healthy Controls; no therapy

NO INTERVENTION

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

Interventions

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.

Also known as: Specific, intensive and high-frequency SL-therapy

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

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.

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The patient is responsive to Levodopa (L-DOPA)
• Having received or being scheduled for DBS

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34808624 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dysarthria

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prof. Peter Fuhr
• Organization: University Hospital Basel

peter.fuhr@usb.ch

0041 61 265

Study Officials

• Peter Fuhr, Prof.Dr.med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: September 12, 2018
• Study Completion: October 24, 2018
• Last Updated: June 2, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)