Parkinson DiseaseNCT01121627
Computer-based Cognitive Training for Parkinson Disease
A study testing Computerized cognitive training in people with Parkinson Disease and Gait, run by Clalit Health Services at 1 site in Israel.
Trial summary
Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Gait
- What is being tested?
- Computerized cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Apr 2012
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD.
- Aged 50-80, living in north region of Israel.
- Receive regular medications for PD.
- Not suffering from irregular cognitive disturbance or MMSE<25.
- Measured 1-3 on the Hoehn \& Yahr scale.
- Have access to a computer and the ability to operate it.
Who cannot join
- Brain operation, including DBS transplant.
- History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
- Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
- Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
- Inability to walk independently.
- Immunodeficiency diseases, active cancer, ischemic diseases.
Show all 9Show fewer
- Vision impairment, partial/full blindness.
- Having participated in similar research or cognitive assessment during the previous year.
- Have received cognitive or gait training under physical therapy or other programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.
The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.
Read the detailed description
Parkinson Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities. Previous studies have revealed some relation between cognitive states and physical functions in healthy adults. Few studies have examined the effect of computer-based cognitive training on various populations. These studies showed a positive emotional-cognitive effect in those populations. This type of intervention plan was also applied to PD patients. However, there are no reports on the effect of intentional cognitive training on gait functions. The purpose of the study is to assess whether cognitive training, designed to improve EF ability, can also improve gait function in PD patients.
- Conditions
- Parkinson Disease, Gait
- Being tested
- Computerized cognitive training
- Keywords
- Computerized Cognitive training, Quality of life, Gait Function, Executive Function
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingOther
A 12 week computerized cognitive training at home with the Attengo™ software program.
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive training | Experimental | A 12 week computerized cognitive training Receives: Other: Computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Function
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
Measured: 18 weeks
Secondary outcomes (2)
Executive function
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
Measured: 18 weeks
Quality of life.
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-run cognitive and motor changes.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionApr 2012
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- Uzi Milman, MD, Principal investigator, Clalit Health ServicesJeffrey M Hausdorff, PhD, Principal investigator, Tel-Aviv Sourasky Medical CenterAnat Mirelman, Phd, Principal investigator, Tel-Aviv Sourasky Medical CenterHagit Atias, BA, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121627
- Sponsor's protocol ID
- K-10-0036-ctil
- Status last verified
- Aug 2015
- First submitted
- 10 May 2010
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24322063
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT01121627
- Acronym / sponsor ID
- K-10-0036-ctil
- Conditions
- Parkinson Disease, Gait
- Keywords
- Computerized Cognitive training, Quality of life, Gait Function, Executive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 May 2010 (estimated)
- 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.
Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.
The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.
Detailed description
Parkinson Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities. Previous studies have revealed some relation between cognitive states and physical functions in healthy adults. Few studies have examined the effect of computer-based cognitive training on various populations. These studies showed a positive emotional-cognitive effect in those populations. This type of intervention plan was also applied to PD patients. However, there are no reports on the effect of intentional cognitive training on gait functions. The purpose of the study is to assess whether cognitive training, designed to improve EF ability, can also improve gait function in PD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive training | Experimental | Other: Computerized cognitive trainingA 12 week computerized cognitive training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic PD.
- Aged 50-80, living in north region of Israel.
- Receive regular medications for PD.
- Not suffering from irregular cognitive disturbance or MMSE<25.
- Measured 1-3 on the Hoehn \& Yahr scale.
Key exclusion criteria (9 listed)
- Brain operation, including DBS transplant.
- History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
- Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
- Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
- Inability to walk independently.
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 |
|---|---|---|
| Computerized cognitive trainingA 12 week computerized cognitive training at home with the Attengo™ software program. | Other | Computerized cognitive training |
Primary outcome
Gait Function
Time frame: 18 weeks
At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.
2 secondary outcomes
Executive function
Time frame: 18 weeks
Quality of life.
Time frame: 18 weeks
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 24 Aug 2015.
- Results publication: PubMed 24322063Milman 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.
Related trials for Parkinson Disease
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Non-small Cell Lung Cancer (NSCLC)
RecruitingObservational study
Parkinson's Disease in Type 1 Gaucher Disease
Parkinson Disease (PD), Type 1 Gaucher Disease
RecruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy
PARKINSON DISEASE (Disorder)
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.
Uzi Milman, MD principal investigator
Clalit Health Services
Jeffrey M Hausdorff, PhD principal investigator
Tel-Aviv Sourasky Medical Center
Anat Mirelman, Phd principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training in people with Parkinson Disease and Gait, run by Clalit Health Services at 1 site in Israel.
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 6 inclusion and 9 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 24 Aug 2015. 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 Israel. 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?
Gait Function (time frame: 18 weeks). 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 NCT01121627, 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 24 Aug 2015.