Parkinson DiseaseNCT04103255
High Frequency and Intensive Prevention Program
A study testing High frequency and intensive prevention program in people with Parkinson Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The treatment of PD has made considerable advances in recent years with respect to drug therapies, as well as many new physiotherapy and drug-based methods, and there have also been great improvements in therapy thanks to deep brain stimulation. Read more about this study
- Who is it for?
- Ages 18 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- High frequency and intensive prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jul 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson syndrome according to United Kingdom Parkinson's Disease Brain Bank Criteria
- mental competence to provide informed consent
- able to understand German sufficiently
Who cannot join
- Severe dementia (DMS-IV, mini mental Status (MMS) <24, moca test (MoCa) <21)
- young onset Parkinson's disease (<18y)
- other neurological or psychiatric diseases of the brain not related to PD
- secondary parkinsonism
- physical impairment hindering the adequate execution of the training
- insufficient knowledge of German
- pregnancy
- Deep Brain Stimulation (DBS) is no exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Frequency Multimodal Training Including Tai Chi for Improving Motor and Cognitive Function in People With Parkinson's Disease
The treatment of PD has made considerable advances in recent years with respect to drug therapies, as well as many new physiotherapy and drug-based methods, and there have also been great improvements in therapy thanks to deep brain stimulation. Cognitive rehabilitation has shown to be effective in PD (Abbruzzese et al., 2016), however, there has yet to be a major breakthrough in the treatment and prevention of PDD (Parkinson's Disease Dementia ). This is where the high frequency and intensive prevention described here comes into play.
Read the detailed description
Cognitive decline is an important and common complication in Parkinson's Disease (PD); approximately 27% of non-demented PD patients have Mild Cognitive Impairment (MCI) (Litvan et al. 2012, Chaudhuri et al., 2011) and up to 80% develop PD dementia (PD-D) over the long term (Hely et al., 2005). Cognitive course in PD is heterogeneous and affects visuospatial, attentional, executive and memory function; studies report different cognitive subtypes and divergent patterns of cognitive decline (Kehagia et al., 2010; Litvan et al., 2011; Williams-Gray et al., 2007; Yarnall et al., 2014). Recently, models have been constructed to estimate individual risk for global cognitive impairment using a small set of predictor variables (Liu et al. 2017; Velseboer et al., 2016). These prediction algorithms were developed in large samples of PD patients and accurately forecast cognitive decline in both, patients with MCI and patients with PD-D and were successfully replicated in independent samples; a score with a predefined cut off point predicts dementia with high positive and negative predictive values (Liu et al., 2017).
The primary aim of this study is the possible stabilization or delay of cognitive decline as well as the improvement of the quality of life of the patients. As secondary outcome, the change in symptoms associated with PD, will be investigated. Psychological states as depression and anxiety, as well as cognitive performance in different areas, for example attention and memory shall be investigated. Neurological symptoms, for example motor function and sleepiness, will also be assessed as secondary parameters and potentially confounding factors.
This study is a 4 week non-randomized controlled trial with one intervention group (HIPP) and one control group (CogniPlus). Primary and secondary outcome measures are assessed at baseline and are repeated after the 4-week intervention period and at 6 month in a follow-up assessment. After 4 weeks there is an intermediate measurement consisting of the primary outcome measures.
The intervention group receives individualized program: the program will be tailored to the patient's needs, strengths and weaknesses, resulting from the initial assessment.
- Tai Chi - "Keep Moving" is an exercise programme for patients with movement disorders that explicitly utilizes the health aspect of Tai Chi movement teachings. Each session lasted 60 minutes and ended with a 10-minute meditation. The Tai Chi sessions in our study were carried out twice a week under the guidance of certified Tai Chi instructors. Details of this program can be found on the following website: https://taiji-therapie.ch/
- CogniFit® - is a online-based personalized cognition training program. This well-validated cognitive training improves attention, working memory, memory, executive function, and visual perceptual functions. Each session lasted 20 minutes and was applied 2-5 times per week based on the results of the baseline tests. The home-based approach took place under the supervision of a psychologist or a specially trained psychology student. The difficulty level was automatically adjusted by the program itself. Details of the program can be found on the following website: https://www.cognifit.com/.
- SpeechCare - (MoveApp) is a home-based approach for patients with Parkinson's disease. The training program uses automatic speech recognition (ASR) and thus can provide feedback on speech intelligibility. Each session lasted 12 minutes and was conducted 1-3 times per week based on the results of the baseline test of SpeechCare . The domestic approach took place under the supervision of a psychologist or a specially trained psychology student. The level of difficulty was manually adjusted as needed. Details of the program can be found on the following website: https://www.speechcare.de/.
The patients in the control group received a computer-assisted cognitive training program: CogniPlus (Schuhfried GmbH, Vienna, Austria). Each training session consisted of different tasks (Focused attention; working memory; planning and action skill; respons inhibition) that were performed for 10 Minutes each. Details of the program can be found on the following website: www.schuhfried.at. The training sessions were supervised by a psychologist or a specially trained student of psychology
- Conditions
- Parkinson Disease
- Being tested
- High frequency and intensive prevention program
- Keywords
- Cognition, Tai Chi
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency and intensive prevention programOther
This study is a 4 week non-randomized controlled trial (RCT)
| Study group | Role | What they receive |
|---|---|---|
| High frequency and intensive prevention | Experimental | High frequency and intensive prevention program
1. Tai Chi
2. CogniFit (cognitive training)
3. SpeechCare (speech training) Receives: Other: High frequency and intensive prevention program |
| Control group (CogniPlus) | Active comparator | Computer-assisted cognitive training program Receives: Other: High frequency and intensive prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory: California Verbal Learning Test (CVLT; Delis, Kramer, Ober, & Kaplan, 1987)
This is a method that tests memory functions, including encoding, retrieval, and recognition processes. The task is to learn in five cycles a shopping list of 16 words assigned to four semantic categories (i.e. beverages, fruits, clothing, tools). As many words as possible should be enumerated after each cycle. The sum of the words stored in the 1-5 cycles is used as the encoding parameter.
Measured: Before and after 4 weeks of training, After 6-month
working memory: Corsi Block Test (Härtig et al., 2000)
Corsi Block Test serve to evaluate the verbal and visual working memory. In the Corsi Block, the test person is presented with a board with irregularly arranged cubes. The task is to remember a sequence of tapped cubes and then to tap the cubes in the same sequence or later to follow the path shown in reverse order. Also with this test the difficulty increases, as the offered sequences become increasingly longer.
The total score for the Digit Span is the sum of 12 items, ranging from 0 (worst possible result) to 12 (best possible result).
The total score for the Corsi Block is the sum of 14 points in forward typing, ranging from 0 (worst score) to 14 (best symptoms) and the sum of 12 points in backward typing from 0 (worst score) to 12 (best symptoms).
Measured: Before and after 4 weeks of training, After 6-month
Visuo-construction: Rey-Osterrieth complex figure (Duley et al., 1993)
The Rey-Osterrieth (ROCF) and Taylor (TCF) complex figure tests are widely used to assess visuospatial and constructional abilities as well as visual/non-verbal Memory (Marie-Pier Tremblay et al., 2015). The score ranging from 0 (worst possible result) to 36 (best possible result).
·
Measured: Before and after 4 weeks of training, After 6-month
Attention: Trail Making Test, part A (J. Perianez et al., 2007)
Trail Making Test, part A serve to evaluate the attention
Measured: Before and after 4 weeks of training, After 6-month
Executive function (flexibility): Wisconsin Card Sorting test, number of errors (H.E. Nelson, 1976)
Wisconsin Card Sorting test serve to evaluate the executive function
Measured: Before and after 4 weeks of training, After 6-month
Secondary outcomes (5)
Electroencephalogram (EEG)
- EEG power in Delta; Theta; Alpha 1; Alpha 2; Beta.
- Brain Network Connectivity
Measured: Before and after 4 weeks of training, After 6-month
Near-infrared spectroscopy
Detecting changes in blood hemoglobin concentrations associated with neural activity
Measured: Before and after 4 weeks of training, After 6-month
Unified Parkinson's Disease Rating Scale UPDRS Part III
This is the standard scale used for grading severity of PD. (UPDRS) - Four Parts Higher score values represent a worse outcome.
Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16; Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25
Measured: Before and after 4 weeks of training, After 6-month
Tinetti Mobility Test (D.A. Kegelmeyer et al., 2007)
Balance and stability assessment
Measured: Before and after 4 weeks of training, After 6-month
Epworth Sleepiness Scale (M.W. Johns, 1991)
Measuring Daytime Sleepiness
Measured: Before and after 4 weeks of training, After 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start10 Jul 2020
- Primary completion1 Nov 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson Schweiz
- Responsible party
- Sponsor
- Investigators
- Peter Fuhr, Prof.Dr.med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103255
- Sponsor's protocol ID
- BSL prevention program
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2019
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Toloraia K, Gschwandtner U, Fuhr P. High-frequency multimodal training with a focus on Tai Chi in people with Parkinson's disease: a pilot study. Front Aging Neurosci. 2024 Feb 15;16:1335951. doi: 10.3389/fnagi.2024.1335951. eCollection 2024.
PubMed 38425785
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Multimodal Training Including Tai Chi for Improving Motor and Cognitive Function in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04103255
- Acronym / sponsor ID
- BSL prevention program
- Conditions
- Parkinson Disease
- Keywords
- Cognition, Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Parkinson Schweiz
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment of PD has made considerable advances in recent years with respect to drug therapies, as well as many new physiotherapy and drug-based methods, and there have also been great improvements in therapy thanks to deep brain stimulation. Cognitive rehabilitation has shown to be effective in PD (Abbruzzese et al., 2016), however, there has yet to be a major breakthrough in the treatment and prevention of PDD (Parkinson's Disease Dementia ). This is where the high frequency and intensive prevention described here comes into play.
Detailed description
Cognitive decline is an important and common complication in Parkinson's Disease (PD); approximately 27% of non-demented PD patients have Mild Cognitive Impairment (MCI) (Litvan et al. 2012, Chaudhuri et al., 2011) and up to 80% develop PD dementia (PD-D) over the long term (Hely et al., 2005). Cognitive course in PD is heterogeneous and affects visuospatial, attentional, executive and memory function; studies report different cognitive subtypes and divergent patterns of cognitive decline (Kehagia et al., 2010; Litvan et al., 2011; Williams-Gray et al., 2007; Yarnall et al., 2014). Recently, models have been constructed to estimate individual risk for global cognitive impairment using a small set of predictor variables (Liu et al. 2017; Velseboer et al., 2016). These prediction algorithms were developed in large samples of PD patients and accurately forecast cognitive decline in both, patients with MCI and patients with PD-D and were successfully replicated in independent samples; a score with a predefined cut off point predicts dementia with high positive and negative predictive values (Liu et al., 2017).
The primary aim of this study is the possible stabilization or delay of cognitive decline as well as the improvement of the quality of life of the patients. As secondary outcome, the change in symptoms associated with PD, will be investigated. Psychological states as depression and anxiety, as well as cognitive performance in different areas, for example attention and memory shall be investigated. Neurological symptoms, for example motor function and sleepiness, will also be assessed as secondary parameters and potentially confounding factors.
This study is a 4 week non-randomized controlled trial with one intervention group (HIPP) and one control group (CogniPlus). Primary and secondary outcome measures are assessed at baseline and are repeated after the 4-week intervention period and at 6 month in a follow-up assessment. After 4 weeks there is an intermediate measurement consisting of the primary outcome measures.
The intervention group receives individualized program: the program will be tailored to the patient's needs, strengths and weaknesses, resulting from the initial assessment.
- Tai Chi - "Keep Moving" is an exercise programme for patients with movement disorders that explicitly utilizes the health aspect of Tai Chi movement teachings. Each session lasted 60 minutes and ended with a 10-minute meditation. The Tai Chi sessions in our study were carried out twice a week under the guidance of certified Tai Chi instructors. Details of this program can be found on the following website: https://taiji-therapie.ch/
- CogniFit® - is a online-based personalized cognition training program. This well-validated cognitive training improves attention, working memory, memory, executive function, and visual perceptual functions. Each session lasted 20 minutes and was applied 2-5 times per week based on the results of the baseline tests. The home-based approach took place under the supervision of a psychologist or a specially trained psychology student. The difficulty level was automatically adjusted by the program itself. Details of the program can be found on the following website: https://www.cognifit.com/.
- SpeechCare - (MoveApp) is a home-based approach for patients with Parkinson's disease. The training program uses automatic speech recognition (ASR) and thus can provide feedback on speech intelligibility. Each session lasted 12 minutes and was conducted 1-3 times per week based on the results of the baseline test of SpeechCare . The domestic approach took place under the supervision of a psychologist or a specially trained psychology student. The level of difficulty was manually adjusted as needed. Details of the program can be found on the following website: https://www.speechcare.de/.
The patients in the control group received a computer-assisted cognitive training program: CogniPlus (Schuhfried GmbH, Vienna, Austria). Each training session consisted of different tasks (Focused attention; working memory; planning and action skill; respons inhibition) that were performed for 10 Minutes each. Details of the program can be found on the following website: www.schuhfried.at. The training sessions were supervised by a psychologist or a specially trained student of psychology
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency and intensive prevention | Experimental | Other: High frequency and intensive prevention programHigh frequency and intensive prevention program 1. Tai Chi 2. CogniFit (cognitive training) 3. SpeechCare (speech training) |
| Control group (CogniPlus) | Active comparator | Other: High frequency and intensive prevention programComputer-assisted cognitive training program |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with idiopathic Parkinson syndrome according to United Kingdom Parkinson's Disease Brain Bank Criteria
- mental competence to provide informed consent
- able to understand German sufficiently
Key exclusion criteria (8 listed)
- Severe dementia (DMS-IV, mini mental Status (MMS) <24, moca test (MoCa) <21)
- young onset Parkinson's disease (<18y)
- other neurological or psychiatric diseases of the brain not related to PD
- secondary parkinsonism
- physical impairment hindering the adequate execution of the training
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 |
|---|---|---|
| High frequency and intensive prevention programThis study is a 4 week non-randomized controlled trial (RCT) | Other | Control group (CogniPlus), High frequency and intensive prevention |
Primary outcome
Episodic memory: California Verbal Learning Test (CVLT; Delis, Kramer, Ober, & Kaplan, 1987)
Time frame: Before and after 4 weeks of training, After 6-month
This is a method that tests memory functions, including encoding, retrieval, and recognition processes. The task is to learn in five cycles a shopping list of 16 words assigned to four semantic categories (i.e. beverages, fruits, clothing, tools). As many words as possible should be enumerated after each cycle. The sum of the words stored in the 1-5 cycles is used as the encoding parameter.
working memory: Corsi Block Test (Härtig et al., 2000)
Time frame: Before and after 4 weeks of training, After 6-month
Corsi Block Test serve to evaluate the verbal and visual working memory. In the Corsi Block, the test person is presented with a board with irregularly arranged cubes. The task is to remember a sequence of tapped cubes and then to tap the cubes in the same sequence or later to follow the path shown in reverse order. Also with this test the difficulty increases, as the offered sequences become increasingly longer. The total score for the Digit Span is the sum of 12 items, ranging from 0 (worst possible result) to 12 (best possible result). The total score for the Corsi Block is the sum of 14 points in forward typing, ranging from 0 (worst score) to 14 (best symptoms) and the sum of 12 points in backward typing from 0 (worst score) to 12 (best symptoms).
Visuo-construction: Rey-Osterrieth complex figure (Duley et al., 1993)
Time frame: Before and after 4 weeks of training, After 6-month
The Rey-Osterrieth (ROCF) and Taylor (TCF) complex figure tests are widely used to assess visuospatial and constructional abilities as well as visual/non-verbal Memory (Marie-Pier Tremblay et al., 2015). The score ranging from 0 (worst possible result) to 36 (best possible result). ·
Attention: Trail Making Test, part A (J. Perianez et al., 2007)
Time frame: Before and after 4 weeks of training, After 6-month
Trail Making Test, part A serve to evaluate the attention
Executive function (flexibility): Wisconsin Card Sorting test, number of errors (H.E. Nelson, 1976)
Time frame: Before and after 4 weeks of training, After 6-month
Wisconsin Card Sorting test serve to evaluate the executive function
5 secondary outcomes
Electroencephalogram (EEG)
Time frame: Before and after 4 weeks of training, After 6-month
Near-infrared spectroscopy
Time frame: Before and after 4 weeks of training, After 6-month
Unified Parkinson's Disease Rating Scale UPDRS Part III
Time frame: Before and after 4 weeks of training, After 6-month
Tinetti Mobility Test (D.A. Kegelmeyer et al., 2007)
Time frame: Before and after 4 weeks of training, After 6-month
Epworth Sleepiness Scale (M.W. Johns, 1991)
Time frame: Before and after 4 weeks of training, After 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 38425785Toloraia K, Gschwandtner U, Fuhr P. High-frequency multimodal training with a focus on Tai Chi in people with Parkinson's disease: a pilot study. Front Aging Neurosci. 2024 Feb 15;16:1335951. doi: 10.3389/fnagi.2024.1335951. eCollection 2024.
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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 High frequency and intensive prevention program in people with Parkinson 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 3 inclusion and 8 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 6 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Episodic memory: California Verbal Learning Test (CVLT; Delis, Kramer, Ober, & Kaplan, 1987) (time frame: Before and after 4 weeks of training, After 6-month). The study lists 5 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 NCT04103255, 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 6 Jan 2023.