Parkinson DiseaseNCT03065127
Investigating Therapies for Freezing of Gait
A study testing Cognitive Training, Cognitive Behavioural Therapy and Proprioceptive Training in people with Parkinson Disease and Gait Disorders, Neurologic, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
Trial summary
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Cognitive Training, Cognitive Behavioural Therapy and Proprioceptive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2017to Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Either gender
- Diagnosed with idiopathic PD by a Neurologist
- Self-reported FOG with the use of UPDRS-II (Question 14)
- Confirmation of present FOG by a movement disorder specialist
- Able to walk 10 meters, unassisted
- Able to understand English instructions
Who cannot join
- A neurological disease other than PD
- Peripheral neuropathy
- Clinically diagnosed with dementia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Waterloo, Ontario, N2L 3C5
About this study
Official title: Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG. Participants in this study will undergo all three types of treatments in a randomized counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.
Read the detailed description
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD), and negatively impacts quality of life (Walton et al., 2015). Furthermore, advanced FOG does not respond well to treatments commonly used in Parkinson's disease (Nutt et al., 2011), therefore warranting the use of adjunct treatment options. The development of potential treatment strategies for FOG should focus on the underlying mechanism. The cross-talk model of FOG proposes that FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to FOG (Lewis \& Barker, 2009). Hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in FOG episodes. Previous studies have demonstrated the efficacy of therapies targeting these domains in PD and healthy individuals, however, these have yet to be explored in FOG. Therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with FOG.
This study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. Sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. Participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. The cognitive training will utilize the "Smartbrain Pro" computer software, which has previously demonstrated efficacy in individuals with Parkinson's disease (Paris et al., 2011). The sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. This training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). The limbic training group will undergo cognitive behavioural therapy (CBT) focusing solely on anxiety symptoms.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Cognitive Training, Cognitive Behavioural Therapy, Proprioceptive Training
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Training the cognitive domain may be accomplished by training various cognitive and executive functions with guided practice focusing on specific skills (e.g. visuospatial processing, executive function, memory, language, and attention). Cognitive training has been demonstrated to be efficacious in several studies in individuals with PD. Given the potential cognitive contribution to FOG episodes, this type of therapy may alleviate FOG by potentially improving upon planning, set-shifting, and/or response inhibition.
Cognitive Behavioural TherapyBehavioural
CBT has been demonstrated to be effective in the remediation of anxiety in individuals with PD. This may be beneficial to individuals experiencing FOG, given the evidence that anxiety may provoke FOG. During periods of elevated anxiety (e.g. walking in a threatening environment), freezers will be able to more efficiently process this limbic load resulting in greater resources available for movement control.
Proprioceptive TrainingBehavioural
Currently, studies investigating proprioceptive training as a treatment in PD are limited. However, this type of training has potential by improving proprioceptive processing. It would be expected that due to this training, when sensorimotor processing is challenged during locomotion (e.g. by removing visual feedback and preventing compensation of proprioception deficits), freezers would experience less decrements to gait due to an enhanced ability to process sensorimotor demands.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Participants will independently complete cognitive exercises on the "Smartbrain Pro" computer software. These exercises aim to train different aspects of executive function. The difficulty level of each exercise will increase relative to each participant's progress. Sessions will last for one hour, occurring twice weekly for a period of 4 weeks. Receives: Behavioral: Cognitive Training |
| Cognitive Behavioural Therapy | Experimental | Participants will undergo one-on-one sessions of cognitive-behavioural therapy (CBT) working with a therapist to establish an individualized CBT plan which will focus on symptoms of anxiety. Participants will complete a total of eight one-hour sessions over 4 weeks. Receives: Behavioral: Cognitive Behavioural Therapy |
| Proprioceptive Training | Experimental | Participants will complete one-on-one sessions a target matching proprioceptive training protocol using their upper and lower limbs. For the upper limb target-reaching task, participants will be seated in front of a surface marked with ten targets. They will first visualize a specified target, then blindfolded and asked to reach towards that target with the blindfold on. The blindfold will then be removed allowing participants to view their performance relative to the target. This task will be repeated for the remaining targets on both sides and for both upper and lower limbs. Participants will complete a total of eight one-hour sessions over 4 weeks. Receives: Behavioral: Proprioceptive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Assessment
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Measured: Change from Baseline at 4 weeks of first treatment phase
Gait Assessment
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Measured: Change from Baseline at 4 weeks of second treatment phase
Gait Assessment
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Measured: Change from Baseline at 4 weeks of third treatment phase
Secondary outcomes (18)
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Measured: Pre-intervention and Post-intervention at week 4 of first treatment phase
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Measured: Pre-intervention and Post-intervention at week 4 of first treatment phase
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Measured: Pre-intervention and Post-intervention at week 4 of second treatment phase
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Measured: Pre-intervention and Post-intervention at week 4 of second treatment phase
Stroop Test
This test assesses inhibitory control and will be administered in a paper-based format.
Measured: Pre-intervention and Post-intervention at week 4 of third treatment phase
Trail-making test
This will also be administered in a paper-based format. This test will assess visuospatial function and set-shifting ability.
Measured: Pre-intervention and Post-intervention at week 4 of third treatment phase
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Measured: Pre-intervention and Post-intervention at week 4 of first treatment phase
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Measured: Pre-intervention and Post-intervention at week 4 of second treatment phase
Passive Joint Angle Matching
This task will be assessed in order to evaluate proprioceptive functioning.
Measured: Pre-intervention and Post-intervention at week 4 of third treatment phase
Parkinson Anxiety Scale
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Measured: Pre-intervention and Post-intervention at week 4 of first treatment phase
Parkinson Anxiety Scale
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Measured: Pre-intervention and Post-intervention at week 4 of second treatment phase
Parkinson Anxiety Scale
The Parkinson Anxiety Scale (PAS), which is a self-report questionnaire used to assess anxiety levels, will be administered to participants. This tool has demonstrated good concurrent validity in individuals with PD against other existing anxiety scales (Leentjens et al., 2014).
Measured: Pre-intervention and Post-intervention at week 4 of third treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Measured: Pre-intervention and Post-intervention at week 4 of first treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Measured: Pre-intervention and Post-intervention at week 4 of second treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
A clinician administered assessment which evaluates individuals' motor symptom severity
Measured: Pre-intervention and Post-intervention at week 4 of third treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Measured: Pre-intervention and Post-intervention at week 4 of first treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Measured: Pre-intervention and Post-intervention at week 4 of second treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Participants will be asked to complete the New Freezing of Gait Questionnaire (NFOGQ) questionnaire developed by Nieuwboer and colleagues (2009). This provides a self-reported measure of frequency and duration of FOG episodes. This tool has been validated and proven to be highly reliable in individuals with PD, as well as assessing treatment interventions for FOG.
Measured: Pre-intervention and Post-intervention at week 4 of third treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start24 Feb 2017
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Chow, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Investigators
- Rebecca Chow, BSc, Principal investigator, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065127
- Sponsor's protocol ID
- SunLife
- Status last verified
- Apr 2017
- First submitted
- 9 Feb 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chow R, Tripp BP, Rzondzinski D, Almeida QJ. Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains. Neurorehabil Neural Repair. 2021 Mar;35(3):290-299. doi: 10.1177/1545968321992331. Epub 2021 Feb 9.
PubMed 33559531
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains
- ClinicalTrials.gov ID
- NCT03065127
- Acronym / sponsor ID
- SunLife
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 27 Feb 2017 (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.
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD). FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia. Therefore, the purpose of this study is to evaluate cognitive, limbic, and sensorimotor therapies in individuals with FOG. Participants in this study will undergo all three types of treatments in a randomized counterbalanced order. Each treatment will occur in 1 hour sessions, twice weekly for a period of 4 weeks.
Detailed description
Freezing of gait (FOG) is arguably one of the most debilitating motor symptoms experienced by individuals with Parkinson's disease (PD), and negatively impacts quality of life (Walton et al., 2015). Furthermore, advanced FOG does not respond well to treatments commonly used in Parkinson's disease (Nutt et al., 2011), therefore warranting the use of adjunct treatment options. The development of potential treatment strategies for FOG should focus on the underlying mechanism. The cross-talk model of FOG proposes that FOG may be caused by an overload of cognitive, limbic, and sensorimotor system activity in the basal ganglia, resulting in a depletion of dopaminergic resources, leading to FOG (Lewis \& Barker, 2009). Hence, based on the cross-talk model, treatments targeting the cognitive, sensorimotor and limbic systems independently may lead to a reduction in FOG episodes. Previous studies have demonstrated the efficacy of therapies targeting these domains in PD and healthy individuals, however, these have yet to be explored in FOG. Therefore, the purpose of this study is to evaluate cognitive, sensorimotor, and limbic therapies in individuals with FOG.
This study will employ a within-subjects design, in which participants will undergo all three treatments in a randomized counterbalanced order. Sessions for each type of treatment will occur for 1 hour, twice weekly for a period of 4 weeks. Participants will also undergo pre- and post-test assessments prior to and following each 4-week treatment period. The cognitive training will utilize the "Smartbrain Pro" computer software, which has previously demonstrated efficacy in individuals with Parkinson's disease (Paris et al., 2011). The sensorimotor training group will participate in proprioceptive training of the upper and lower limbs. This training will entail a target matching task, in which participants will produce active and self-defined movements while blindfolded (i.e. without visual feedback). The limbic training group will undergo cognitive behavioural therapy (CBT) focusing solely on anxiety symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingParticipants will independently complete cognitive exercises on the "Smartbrain Pro" computer software. These exercises aim to train different aspects of executive function. The difficulty level of each exercise will increase relative to each participant's progress. Sessions will last for one hour, occurring twice weekly for a period of 4 weeks. |
| Cognitive Behavioural Therapy | Experimental | Behavioral: Cognitive Behavioural TherapyParticipants will undergo one-on-one sessions of cognitive-behavioural therapy (CBT) working with a therapist to establish an individualized CBT plan which will focus on symptoms of anxiety. Participants will complete a total of eight one-hour sessions over 4 weeks. |
| Proprioceptive Training | Experimental | Behavioral: Proprioceptive TrainingParticipants will complete one-on-one sessions a target matching proprioceptive training protocol using their upper and lower limbs. For the upper limb target-reaching task, participants will be seated in front of a surface marked with ten targets. They will first visualize a specified target, then blindfolded and asked to reach towards that target with the blindfold on. The blindfold will then be removed allowing participants to view their performance relative to the target. This task will be repeated for the remaining targets on both sides and for both upper and lower limbs. Participants will complete a total of eight one-hour sessions over 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Either gender
- Diagnosed with idiopathic PD by a Neurologist
- Self-reported FOG with the use of UPDRS-II (Question 14)
- Confirmation of present FOG by a movement disorder specialist
- Able to walk 10 meters, unassisted
Key exclusion criteria (3 listed)
- A neurological disease other than PD
- Peripheral neuropathy
- Clinically diagnosed with dementia
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 |
|---|---|---|
| Cognitive TrainingTraining the cognitive domain may be accomplished by training various cognitive and executive functions with guided practice focusing on specific skills (e.g. visuospatial processing, executive function, memory, language, and attention). Cognitive training has been demonstrated to be efficacious in several studies in individuals with PD. Given the potential cognitive contribution to FOG episodes, this type of therapy may alleviate FOG by potentially improving upon planning, set-shifting, and/or response inhibition. | Behavioural | Cognitive Training |
| Cognitive Behavioural TherapyCBT has been demonstrated to be effective in the remediation of anxiety in individuals with PD. This may be beneficial to individuals experiencing FOG, given the evidence that anxiety may provoke FOG. During periods of elevated anxiety (e.g. walking in a threatening environment), freezers will be able to more efficiently process this limbic load resulting in greater resources available for movement control. | Behavioural | Cognitive Behavioural Therapy |
| Proprioceptive TrainingCurrently, studies investigating proprioceptive training as a treatment in PD are limited. However, this type of training has potential by improving proprioceptive processing. It would be expected that due to this training, when sensorimotor processing is challenged during locomotion (e.g. by removing visual feedback and preventing compensation of proprioception deficits), freezers would experience less decrements to gait due to an enhanced ability to process sensorimotor demands. | Behavioural | Proprioceptive Training |
Primary outcome
Gait Assessment
Time frame: Change from Baseline at 4 weeks of first treatment phase
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Gait Assessment
Time frame: Change from Baseline at 4 weeks of second treatment phase
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
Gait Assessment
Time frame: Change from Baseline at 4 weeks of third treatment phase
Participants will walk approximately 9.75 metres for 12 trials. Recording of kinematic data will be done with eight Optotrak® cameras (Northern Digital, NDI, Waterloo, Ontario). Spatiotemporal gait parameters will be analyzed from this assessment.
18 secondary outcomes
Stroop Test
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Trail-making test
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Stroop Test
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Trail-making test
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Stroop Test
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Trail-making test
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Passive Joint Angle Matching
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Passive Joint Angle Matching
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Passive Joint Angle Matching
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Parkinson Anxiety Scale
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Parkinson Anxiety Scale
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Parkinson Anxiety Scale
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
Unified Parkinson's disease Rating Scale Motor Subsection (UPDRS-III)
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: Pre-intervention and Post-intervention at week 4 of first treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: Pre-intervention and Post-intervention at week 4 of second treatment phase
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: Pre-intervention and Post-intervention at week 4 of third treatment phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 33559531Chow R, Tripp BP, Rzondzinski D, Almeida QJ. Investigating Therapies for Freezing of Gait Targeting the Cognitive, Limbic, and Sensorimotor Domains. Neurorehabil Neural Repair. 2021 Mar;35(3):290-299. doi: 10.1177/1545968321992331. Epub 2021 Feb 9.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Rebecca Chow, BSc principal investigator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training, Cognitive Behavioural Therapy and Proprioceptive Training in people with Parkinson Disease and Gait Disorders, Neurologic, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. 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 Canada. 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?
Results are not available in the source record.
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 Assessment (time frame: Change from Baseline at 4 weeks of first treatment phase). The study lists 3 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 NCT03065127, 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 25 Apr 2017.