Parkinson's DiseaseEILTNCT02935842

Evaluation of Intensive Language Therapy

A study testing Specific SL-therapy and Rhythmic Balance-Movement Training (rBMT) in people with Parkinson's Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
What is being tested?: Specific SL-therapy and Rhythmic Balance-Movement Training (rBMT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteSwitzerland
Study dates: 1 Oct 2016to 24 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Basel
Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions: Parkinson's Disease
Being tested: Specific SL-therapy, Rhythmic Balance-Movement Training (rBMT)
Keywords: Parkinson's Disease, Word Retrieval, Apraxia Symptoms, Dysarthria
Medical subject headings: Parkinson Disease, Dysarthria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Specific SL-therapyOther
Also called Specific, intensive and high-frequency 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)Other
Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.

Study groups in NCT02935842
Study group	Role	What they receive
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 Receives: 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 Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Velocity in Gait
Gait Velocity: meters per second
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).

Secondary outcomes (3)

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.
Measured: At Baseline and 6 Months
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.
Measured: At 4 Weeks and 6 Months
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
Measured: At 4 Weeks and at 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201624 Oct 2018

First posted18 Oct 2016 (estimated)
Study start1 Oct 2016
Primary completion12 Sep 2018
Study completion24 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02935842
Sponsor's protocol ID: EILT
Acronym: EILT
Status last verified: May 2020
First submitted: 18 Aug 2016
Last updated: 2 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 34808624

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
RecruitingPhase 2/3
A Study of Buntanetap in Participants With PD
Parkinson's Disease (PD), Deep Brain Stimulation

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02935842
Acronym / sponsor ID: EILT / EILT
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Word Retrieval, Apraxia Symptoms, Dysarthria
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University Hospital, Basel, SwitzerlandUniversity, hospital or other
Study start: 1 Oct 2016 (actual)
Primary completion: 12 Sep 2018 (actual)
Study completion: 24 Oct 2018 (actual)
First posted: 18 Oct 2016 (estimated)
Results: Posted 2 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Specific SL-therapy for PD (with and without DBS)	Experimental	Other: Specific SL-therapy, Other: Rhythmic Balance-Movement Training (rBMT)Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks
rBMT for PD (with and without DBS)	Active comparator	Other: Specific SL-therapy, Other: Rhythmic Balance-Movement Training (rBMT)Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks
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.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Specific SL-therapyAlso: Specific, intensive and high-frequency SL-therapyProvided 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	Specific SL-therapy for PD (with and without DBS), rBMT for PD (with and without DBS)
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.	Other	Specific SL-therapy for PD (with and without DBS), rBMT for PD (with and without DBS)

Primary outcome

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
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.
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.
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.

3 secondary outcomes

Health Status (UPDRS)
Time frame: At Baseline and 6 Months
Neuropsychiatric Self-rating Questionnaires
Time frame: At 4 Weeks and 6 Months
Neuropsychological Standardised Test Battery
Time frame: At 4 Weeks and at 6 Months

Results and safety

Results posted to the registry on 2 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rSLT, Then no Therapy, Then rBMT	8	8
rBMT, Then 'no Therapy', Then rSLT	6	6
No Therapy, Then rSLT, Then rBMT	6	6
Healthy Controls; no Therapy	0	0

Primary outcome: Velocity in Gait

Time frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).. Mean (Standard Deviation). Unit: meter per second

Measure	Specific SL-therapy for PD-DBS and Non-DBS n = 16	rBMT for PD-DBS and Non-DBS n = 10	PD-DBS/ Non-DBS; no Therapy n = 18	Healthy Controls; no Therapy n = 17
Gait Velocity-4W (4Weeks)	1.2 (.2)	1.2 (.3)	1.2 (.3)	.8 (.08)
Gait Velocity-6M (6 Months)	1.3 (.8)	1.2 (.4)	1.2 (.3)	.8 (.08)

Specific SL-therapy for PD-DBS and Non-DBS vs rBMT for PD-DBS and Non-DBS vs PD-DBS/ Non-DBS; no Therapy vs Healthy Controls; no Therapy: p = .05, ANOVA

Primary outcome: Cadence in Gait

Time frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).. Mean (Standard Deviation). Unit: steps per second

Measure	Specific SL-therapy for PD (With and Without DBS) n = 16	rBMT for PD (With and Without DBS) n = 10	PD (With and Without DBS); no Therapy n = 18	Healthy Controls; no Therapy n = 17
Gait Cadence-4W	2.5 (.3)	2.5 (.6)	2.7 (.7)	1.7 (.2)
Gait Cadence-6M	2.8 (.8)	2.7 (.8)	2.7 (.7)	1.7 (.2)

Primary outcome: Speech Velocity

Time frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).. Mean (Standard Deviation). Unit: spoken syllables per second

Measure	rSLT, Then no Therapy, Then rBMT n = 16	rBMT, Then rSLT, Then no Therapy n = 10	No Therapy, Then rSLT or rBMT, Then rBMT or rSLT n = 18	Healthy Controls; no Therapy n = 17
Speech velocity 4W	3.6 (.7)	4.2 (.9)	4.9 (.7)	2.3 (.6)
Speech velocity 6M	3.8 (.8)	4.8 (.9)	4.9 (.6)	2.3 (.6)

Primary outcome: Speech Cadence

Time frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).. Mean (Standard Deviation). Unit: spoken syllables per inspiration

Measure	rSLT, Then no Therapy, Then rBMT n = 16	rBMT, Then rSLT, Then no Therapy n = 10	No Therapy, Then rSLT or rBMT, Then rBMT or rSLT n = 18	Healthy Controls; no Therapy n = 17
Speech Cadence 4W	15.6 (3.6)	13.1 (4.7)	10.9 (3.9)	21.6 (6)
Speech Cadence 6M	13.3 (4.6)	13.6 (4.7)	10.5 (3.5)	21.6 (6)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected over the full length of the study for each participant. Beginning at the baseline measurement up to 1 year after completion.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Specific SL-therapy for PD-DBS and Non-DBS	0 of 20 (0%)	0 of 20 (0%)	0 of 20
rBMT for PD-DBS and Non-DBS	0 of 20 (0%)	0 of 20 (0%)	1 of 20
PD-DBS/ Non-DBS; no Therapy	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Healthy Controls; no Therapy	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34808624Roesch 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.
Individual participant dataSharing planned: No

Related trials for Parkinson's Disease

Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
RecruitingPhase 2/3
A Study of Buntanetap in Participants With PD
Parkinson's Disease (PD), Deep Brain Stimulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Fuhr, Prof.Dr.med. principal investigator

University Hospital, Basel, Switzerland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Specific SL-therapy and Rhythmic Balance-Movement Training (rBMT) in people with Parkinson's Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Velocity in Gait (time frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.