University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT04103255
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.
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Notify Me18 year–86 year
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
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.
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This study is a 4 week non-randomized controlled trial (RCT)
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.
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).
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).
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Time frame: Before and after 4 weeks of training, After 6-month
Trail Making Test, part A serve to evaluate the attention
Time frame: Before and after 4 weeks of training, After 6-month
Wisconsin Card Sorting test serve to evaluate the executive function
Time frame: Before and after 4 weeks of training, After 6-month
Time frame: Before and after 4 weeks of training, After 6-month
Detecting changes in blood hemoglobin concentrations associated with neural activity
Time frame: Before and after 4 weeks of training, After 6-month
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
Time frame: Before and after 4 weeks of training, After 6-month
Balance and stability assessment
Time frame: Before and after 4 weeks of training, After 6-month
Measuring Daytime Sleepiness
University Hospital, Basel, Switzerland
Other
High Frequency Multimodal Training Including Tai Chi for Improving Motor and Cognitive Function in People With Parkinson's Disease
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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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