- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514379
Effect of Cognitive Training on Gait in Parkinson's Disease
September 13, 2023 updated by: Evžen Růžička, General University Hospital, Prague
Disorders of Gait, Postural Stability and Cognition in Parkinson's Disease: Presymptomatic Detection and Targeted Rehabilitation
Physiotherapy and targeted rehabilitation are routinely performed in order to influence disorders of posture, gait and stability in Parkinson´s disease (PD), but their effects have been controversial (Keus et al. 2014; Walton wt al. 2014).
Recently, several studies suggested that cognitive training can improve gait in patients with PD (Peterson et al. 2016, Heremans et al. 2013), similar to the effects seen in the elderly (Yogev-Seligmann et al. 2008; Amboni et al. 2013).
Specific training programs including dual tasking with automatic verbal series, counting etc. have led to increased walking speed and improved stepping cadence, length, and duration in patients with dementia (Schwenk et al. 2010).
However, since in advanced PD patients dual-task gait training has to be supervised by therapists, it is not a suitable type of therapy to be performed at home.
Therefore, this study aims to verify and extend the encouraging results of the single study which showed a positive effect of cognitive function training on gait in PD (Milman et al. 2014) by exploring this effect in advanced PD patients, by assessing the effect on gait using more targeted clinical and instrumental evaluation, and by comparing two modes of therapy delivery, group and computer-based.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
- Background: In a pilot study, Milman et al. 2014 showed that computer-based cognitive training focusing on executive function and attention performed at home might improve selected gait parameters in early patients with Parkinson´s disease (PD).
- Goal 1: To explore this effect in advanced PD patients
- Hypothesis 1: Effect of cognitive training focusing on executive function and attention will be detected also in advanced PD patients and this effect will be larger as compared to the results published by Milman et al. 2014.
- Goal 2: To verify the results published by Milman et al. 2014 using more targeted clinical and instrumental gait assessment, including dual-task gait evaluation as well as instrumental testing of turn fluency (Bertoli et al. 2019).
- Hypothesis 2: The results published by Milman et al. 2014 will be confirmed and an effect on dual-task gait and turn fluency will be shown.
- Goal 3: To explore the role of the form of therapy setting, i.e. whether group setting might increase the effect of cognitive training on gait as compared to individual cognitive training at home. Such results have been shown in the case of a physiotherapy intervention by King et al. 2015.
- Hypothesis 3: The effect of group cognitive training on gait will be larger as compared to individual dose-matched, computer-based cognitive training performed at home. However, it remains to be determined whether the effect size difference between the two groups will outweigh the advantages of tele-rehabilitation.
- Design: Randomised-controlled trial
- Interventions: experimental group: group cognitive training focusing on executive function and attention; control group: computer-based cognitive training focusing on executive function and attention performed at home. Intervention in both groups will be dose-matched (experimental: 60 mins, 2x/week, 12 weeks; control: 30 mins, 4x/week, 12 weeks)
- Follow-up: at 1 and 3 months time points.
- Power analysis results: at least 38 patients.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czechia, 12821
- General University Hospital in Prague
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosis of Parkinson´s disease (PD)
- PD duration ≥8 years
- mild cognitive impairment
- stable medication
- presence of freezing of gait according to the FoG-Q AND/OR Rapid Turns Test
Exclusion Criteria:
- dementia
- deep brain stimulation, pump therapy with Duodopa or Apomorphine
- severe fluctuations with ON state duration for less than 2 hours
- dopa dysregulation syndrome
- impulse control disorder
- untreated depression
- benzodiazepines except for single dose at night
- non-compliance
- inability to walk without support
- significant co-morbidities likely to affect gait, e.g., acute illness, orthopedic disease, significant visual problems, or a clinical history of stroke
- involvement in other treatment trials
- not meeting inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group cognitive training
The experimental group will undergo 60 minutes long cognitive training group sessions twice a week for 12 weeks focused on executive function, attention and working memory.
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Cognitive training focused on executive function, attention and working memory delivered either by the therapist in a group setting (experimental group) or by a specialized software for cognitive training (Rehacom) at home.
|
Active Comparator: Home-based cognitive training
The control group will perform executive function, attention and working memory training similar to the experimental group but at home as instructed by their therapist using specialized software for cognitive training (Rehacom).
This training will be dose matched to the experimental group, i.e. it will be performed four times a week for 30 minutes for 12 weeks.
In this group, therapists will only provide coaching once a month.
|
Cognitive training focused on executive function, attention and working memory delivered either by the therapist in a group setting (experimental group) or by a specialized software for cognitive training (Rehacom) at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline instrumental assessment of turn fluency during rapid turns at 12 weeks
Time Frame: Baseline and 12 weeks
|
see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
|
Baseline and 12 weeks
|
Change from Baseline Timed Up and Go Test: dual-task performance at 12 weeks
Time Frame: Baseline and 12 weeks
|
Patient is asked to perform TUG while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go Test: single-task performance
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
G-Walk instrumental gait assessment will be used
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
10-meter walking test: single-task performance
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
G-Walk instrumental gait assessment will be used
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
10-meter walking test: dual-task performance
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
Patient is asked to perform 10MWT while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
Number of steps/day
Time Frame: 5 days monitoring at baseline and 12 weeks
|
Assessed using Fitbit activity trackers
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5 days monitoring at baseline and 12 weeks
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The Montreal Cognitive Assessment (MoCA), Total score
Time Frame: Baseline, 12 weeks, 3 months follow-up
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Global cognition screening
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Baseline, 12 weeks, 3 months follow-up
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Trail Making Test A (TMT A), Total score (in seconds)
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of attention distribution.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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The Victoria Version of Stroop Test (VST): Dot Time Score (in seconds) Neutral Word Time Score (in seconds) The Victoria Version of Stroop Test (VST): Dot Time Score (in seconds) Neutral Word Time Score (in seconds)
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of focused visual attention
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
The Victoria Version of Stroop Test (VST): Color Word Time Score (in seconds) Error score on VST Color Word Task, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of executive functions - inhibition
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Tower of London, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of executive functions - problem solving
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Depression, Anxiety and Stress Scale (DASS 21)
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Self-assessment scale of depression, anxiety and stress.
Patient fills it at home.
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Falls Efficacy Scale-International
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Fear of falls assessment
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Number of falls
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Diary based quantification of the number of falls
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Change from post-intervention instrumental assessment of turn fluency during rapid turns at 1 month follow-up
Time Frame: 12 weeks and 1 month follow-up
|
see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
|
12 weeks and 1 month follow-up
|
Change from post-intervention instrumental assessment of turn fluency during rapid turns at 3 months follow-up
Time Frame: 12 weeks and 3 months follow-up
|
see Bertoli et al. 2019 for a detailed description; G-Walk instrumental gait assessment will be used
|
12 weeks and 3 months follow-up
|
Change from post-intervention Timed Up and Go Test: dual-task performance at 1 month follow-up
Time Frame: 12 weeks and 1 month follow-up
|
Patient is asked to perform TUG while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
|
12 weeks and 1 month follow-up
|
Change from post-intervention Timed Up and Go Test: dual-task performance at 3 months follow-up
Time Frame: 12 weeks and 3 months follow-up
|
Patient is asked to perform TUG while subtracting 3 from a random number between 51-100; G-Walk instrumental gait assessment will be used
|
12 weeks and 3 months follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Counting: number of (correct) answers per second
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
Patient is asked to subtract 3 from a random number between 51-100 while seated.
This assessment is used as a reference value for TUG-DT and 10MWT-DT
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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MDS-Unified Parkinson's Disease Rating Scale
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Scale evaluating various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Freezing of Gait Questionnaire
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Subjective evaluation of freezing of gait
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Quantitative MRI metrics
Time Frame: Baseline
|
Volumetric parameters
|
Baseline
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Quantitative MRI metrics
Time Frame: Baseline
|
Vascular white matter lesional volume
|
Baseline
|
Quantitative MRI metrics
Time Frame: Baseline
|
Resting functional connectivity
|
Baseline
|
Auditory Verbal Learning Test (AVLT): T1 (Try) T2 T3 T4 T5 T1-5 Total score Interfence, Total score T6, Total score Delayed recall, Total score Recognition, Correct answers total score, False answers total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of auditory memory, memory capacity, ability to learn, delayed recall, recognition
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Phonemic Verbal Fluency FAS, letters: K, P, S Letter K, Total score Letter P, Total Score Letter S, Total score Letters K, P, S, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of executive functions - initation, maintenance, stop and end the activity
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Semantic Fluency, category: Animals, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of phatic functions.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Trail Making Test B (TMT B): Total score (in seconds), Number of errors
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of executive functions - cognitive flexibility.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score Digit Span Forward, Wechsler Adult Intelligence Scale-Revised, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of focused auditory attention.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Digit Span Backward, Wechsler Adult Intelligence Scale-Revised, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Working memory capacity measurement.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Digit Symbol, Wechsler Adult Intelligence Scale-Revised, Total score
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of divided attention and working memory.
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Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Grooved Pegboard, Left.
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Assessing of visual-motor coordination.
The Grooved Pegboard is a manipulative dexterity test consisting of 25 holes with randomly positioned slots.
Pegs with a key along one side must be rotated to match the hole before they can be inserted.
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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The Parkinson´s Disease Questionnaire (PDQ-39)
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Self-assessment quality of life scale for patients with Parkinson's disease.
Patient fills it at home.
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Grooved Pegboard, Right.
Time Frame: Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
|
Assessing of visual-motor coordination.
The Grooved Pegboard is a manipulative dexterity test consisting of 25 holes with randomly positioned slots.
Pegs with a key along one side must be rotated to match the hole before they can be inserted.
|
Baseline, 12 weeks, 1 month follow-up, 3 months follow-up
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Exploratory assessment of relationship between clinical effects of cognitive training and blood signature of polymorphisms in PD-related genes
Time Frame: Baseline
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Custom genetic panel (SureSelect, Agilent) for mutational analysis of 177 genes (including APOE, MAPT, GBA LRRK2, etc.)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Evzen Ruzicka, Prof., General University Hospital, Prague
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321.
- Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.
- Keus SHJ MM, Graziano M, et al. European Physiotherapy Guideline for Parkinson´s Disease. the Netherlands: KNGF/ParkinsonNet,2014.
- Peterson DS, King LA, Cohen RG, Horak FB. Cognitive Contributions to Freezing of Gait in Parkinson Disease: Implications for Physical Rehabilitation. Phys Ther. 2016 May;96(5):659-70. doi: 10.2522/ptj.20140603. Epub 2015 Sep 17.
- Schwenk M, Zieschang T, Oster P, Hauer K. Dual-task performances can be improved in patients with dementia: a randomized controlled trial. Neurology. 2010 Jun 15;74(24):1961-8. doi: 10.1212/WNL.0b013e3181e39696. Epub 2010 May 5.
- Bertoli M, Croce UD, Cereatti A, Mancini M. Objective measures to investigate turning impairments and freezing of gait in people with Parkinson's disease. Gait Posture. 2019 Oct;74:187-193. doi: 10.1016/j.gaitpost.2019.09.001. Epub 2019 Sep 5.
- King LA, Wilhelm J, Chen Y, Blehm R, Nutt J, Chen Z, Serdar A, Horak FB. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. J Neurol Phys Ther. 2015 Oct;39(4):204-12. doi: 10.1097/NPT.0000000000000101.
- Amboni M, Barone P, Hausdorff JM. Cognitive contributions to gait and falls: evidence and implications. Mov Disord. 2013 Sep 15;28(11):1520-33. doi: 10.1002/mds.25674.
- Walton CC, Shine JM, Mowszowski L, Naismith SL, Lewis SJ. Freezing of gait in Parkinson's disease: current treatments and the potential role for cognitive training. Restor Neurol Neurosci. 2014;32(3):411-22. doi: 10.3233/RNN-130370.
- Heremans E, Nieuwboer A, Spildooren J, Vandenbossche J, Deroost N, Soetens E, Kerckhofs E, Vercruysse S. Cognitive aspects of freezing of gait in Parkinson's disease: a challenge for rehabilitation. J Neural Transm (Vienna). 2013 Apr;120(4):543-57. doi: 10.1007/s00702-012-0964-y. Epub 2013 Jan 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Estimated)
October 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
August 15, 2022
First Submitted That Met QC Criteria
August 22, 2022
First Posted (Actual)
August 24, 2022
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU20-04-00327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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