Parkinson DiseaseSCS for FOG OLNCT06272955
LONG TERM EFFECTS OF SPINAL CORD STIMULATION
An observational study of Parkinson Disease, run by Nora Vanegas at 1 site in United States.
Trial summary
Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Spinal Cord Stimulator (SCS)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to 30 Jun 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were enrolled in H-49023 Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease, will be given the option to enroll in this study.
Who may be able to join
- Ability to sign inform consent
- Underwent SCS implantation as part of participation in H-49023
Who cannot join
- Severe dementia Inability to participate in motor or cognitive assessments assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LONG TERM EFFECTS OF SPINAL CORD STIMULATION IN PATIENTS WITH PARKINSON'S DISEASE OPEN LABEL EXTENSION TO H-49023
Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.
The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.
- Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
- Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait.
Read the detailed description
Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits.
FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG.
Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features.
Patients with PD may be able to undergo SCS implantation through experimental protocols such as study H-49023 (NCT03526991) at BCM. We seek to understand the long-term effects of SCS in PD in patients who have participated in H-49023 at BCM.
The current study will use similar assessments as were used in H-49023. Patients will undergo assessments and questionnaires to help identify which setting and parameters produce the best results for the patient. These questionnaires will asses if the patient fell at home and if any non-motor symptoms arise.
- Conditions
- Parkinson Disease
- Being tested
- Spinal Cord Stimulator (SCS)
- Keywords
- Spinal cord stimulation, Locomotion, Freezing of Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulator (SCS)Device
Also called Proclaim™ Implantable Pulse Generator with leads
Patients are already implanted with device from the H-49023 study.
The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads will be implanted percutaneously into the epidural space.
The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of Adverse Events as assessed by Adverse Event reporting.
Measured: 12-months
Secondary outcomes (11)
New Freezing of Gait Questionnaire (NFOG-Q) score
The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life. The task ratings and scales are calculated into a summed NFOG-Q score. The scale is scored from 0-28. A score of 0 means least severe. A score of 28 means the most severe.
Measured: 12month follow up period
Gait and Falls Questionnaire (GFQ)
The Gait and Falls Questionnaire (GFQ) is a clinician-administered tool that aims to assess the specific time when the person experiences freezing of Gait as well as how often they fall. The task ratings and scales are calculated into a summed GFQ score. The scale is scored from 0-64. A score of 0 means least severe. A score of 64 means the most severe.
Measured: 12month follow up period
MDS-UPDRS score
The Movement Disorder Society (MDS) published a revision of the unified Parkinson's disease rating scale, known as the MDS-UPDRS. The Part III: Motor Examination portion of the scale assesses the motor signs of PD and is completed by the examiner. The measure is scored between 0-76 with 0 have the most abnormal motor signs and 76 having normal motor signs.
Measured: 12month follow up period
Timed Up and Go test (TUG)
The Timed Up and Go test measures gait velocity. The Timed Up and Go test is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.
Measured: 12month follow up period
Timed 10-meter walk (T10MW)
The 10-meter walk measures gait velocity. The 10-meter walk is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.
Measured: 12month follow up period
Mini-Mental State Examination (MMSE)
This is a test of cognitive function used to screen and track cognitive changes over time. The MMSE is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.
Measured: 12month follow up period
Montreal Cognitive Assessment Scale (MoCA)
This is a test of cognitive function used to screen and track cognitive changes over time. The MoCA is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.
Measured: 12month follow up period
Beck Depression Inventory (BDI-2)
The Beck Depression Inventory (BDI-2) is a 21-item, self-report rating inventory that measures characteristic, attitudes, and symptoms of depression during the past 2 weeks. The score range is 0-63. A total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: 12month follow up period
Beck Anxiety Inventory (BAI)
The BAI is a 21 self-reported items questionnaire that assess the intensity of physical and cognitive anxiety symptoms during the past week. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
Measured: 12month follow up period
Parkinson's Disease Questionnaire - 39 (PDQ39)
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life. The measure is scored between 0 - 100 with 0 meaning no health problems and 100 meaning more health problems.
Measured: 12month follow up period
Non-Motor Symptoms Scale (NMSS)
Symptoms assessed over the last month. Each symptom scored with respect to: Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. The measure is scored between 0 - 360, with 0 meaning there are no non-motor symptoms and 360 meaning there are non-motor symptoms.
Measured: 12month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start4 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nora Vanegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nora Vanegas, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272955
- Sponsor's protocol ID
- H-54417
- Acronym
- SCS for FOG OL
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.
PubMed 9159723Schoneburg B, Mancini M, Horak F, Nutt JG. Framework for understanding balance dysfunction in Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1474-82. doi: 10.1002/mds.25613. Epub 2013 Aug 7.
PubMed 23925954Giladi N, Kao R, Fahn S. Freezing Phenomenon , the Fifth Cardinal Sign of Parkinsonism Freezing Phenomenon in Patients with Parkinsonian Syndromes. 2016;(January). doi:10.1007/978-1-4615-5337-3.
Espay AJ, Fasano A, van Nuenen BF, Payne MM, Snijders AH, Bloem BR. "On" state freezing of gait in Parkinson disease: a paradoxical levodopa-induced complication. Neurology. 2012 Feb 14;78(7):454-7. doi: 10.1212/WNL.0b013e3182477ec0. Epub 2012 Jan 18.
PubMed 22262741Fasano A, Lozano AM. Deep brain stimulation for movement disorders: 2015 and beyond. Curr Opin Neurol. 2015 Aug;28(4):423-36. doi: 10.1097/WCO.0000000000000226.
PubMed 26110808Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
PubMed 21865071Soltani F, Lalkhen A. Improvement of Parkinsonian Symptoms With Spinal Cord Stimulation: Consequence or Coincidence? J Neurol Neurosurg Psychiatry. 2013;84(11):e2.74-e2. doi:10.1136/jnnp-2013-306573.165.
Hassan S, Amer S, Alwaki A, Elborno A. A patient with Parkinson's disease benefits from spinal cord stimulation. J Clin Neurosci. 2013 Aug;20(8):1155-6. doi: 10.1016/j.jocn.2012.08.018. Epub 2013 Feb 26.
PubMed 23453160Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
PubMed 27862267Rohani M, Kalsi-Ryan S, Lozano AM, Fasano A. Spinal cord stimulation in primary progressive freezing of gait. Mov Disord. 2017 Sep;32(9):1336-1337. doi: 10.1002/mds.27103. Epub 2017 Jul 6. No abstract available.
PubMed 28681922Giladi N, Tal J, Azulay T, Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe WH, Stocchi F, Tolosa E. Validation of the freezing of gait questionnaire in patients with Parkinson's disease. Mov Disord. 2009 Apr 15;24(5):655-61. doi: 10.1002/mds.21745.
PubMed 19127595de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
PubMed 16713924Shulman JM, De Jager PL, Feany MB. Parkinson's disease: genetics and pathogenesis. Annu Rev Pathol. 2011;6:193-222. doi: 10.1146/annurev-pathol-011110-130242.
PubMed 21034221Turner BM, Forstmann BU, Love BC, Palmeri TJ, Van Maanen L. Approaches to Analysis in Model-based Cognitive Neuroscience. J Math Psychol. 2017 Feb;76(B):65-79. doi: 10.1016/j.jmp.2016.01.001. Epub 2016 Feb 17.
PubMed 31745373Snijders AH, Takakusaki K, Debu B, Lozano AM, Krishna V, Fasano A, Aziz TZ, Papa SM, Factor SA, Hallett M. Physiology of freezing of gait. Ann Neurol. 2016 Nov;80(5):644-659. doi: 10.1002/ana.24778. Epub 2016 Oct 7.
PubMed 27649270
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LONG TERM EFFECTS OF SPINAL CORD STIMULATION IN PATIENTS WITH PARKINSON'S DISEASE OPEN LABEL EXTENSION TO H-49023
- ClinicalTrials.gov ID
- NCT06272955
- Acronym / sponsor ID
- SCS for FOG OL / H-54417
- Conditions
- Parkinson Disease
- Keywords
- Spinal cord stimulation, Locomotion, Freezing of Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nora VanegasUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.
The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.
- Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
- Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait.
Detailed description
Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits.
FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG.
Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features.
Patients with PD may be able to undergo SCS implantation through experimental protocols such as study H-49023 (NCT03526991) at BCM. We seek to understand the long-term effects of SCS in PD in patients who have participated in H-49023 at BCM.
The current study will use similar assessments as were used in H-49023. Patients will undergo assessments and questionnaires to help identify which setting and parameters produce the best results for the patient. These questionnaires will asses if the patient fell at home and if any non-motor symptoms arise.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were enrolled in H-49023 Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease, will be given the option to enroll in this study.
Key inclusion criteria (2 listed)
- Ability to sign inform consent
- Underwent SCS implantation as part of participation in H-49023
Key exclusion criteria (1 listed)
- Severe dementia Inability to participate in motor or cognitive assessments assessments
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 |
|---|---|---|
| Spinal Cord Stimulator (SCS)Also: Proclaim™ Implantable Pulse Generator with leadsPatients are already implanted with device from the H-49023 study. The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads will be implanted percutaneously into the epidural space. The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental. | Device | – |
Primary outcome
Safety and Tolerability
Time frame: 12-months
Incidence of Adverse Events as assessed by Adverse Event reporting.
11 secondary outcomes
New Freezing of Gait Questionnaire (NFOG-Q) score
Time frame: 12month follow up period
Gait and Falls Questionnaire (GFQ)
Time frame: 12month follow up period
MDS-UPDRS score
Time frame: 12month follow up period
Timed Up and Go test (TUG)
Time frame: 12month follow up period
Timed 10-meter walk (T10MW)
Time frame: 12month follow up period
Mini-Mental State Examination (MMSE)
Time frame: 12month follow up period
Montreal Cognitive Assessment Scale (MoCA)
Time frame: 12month follow up period
Beck Depression Inventory (BDI-2)
Time frame: 12month follow up period
Beck Anxiety Inventory (BAI)
Time frame: 12month follow up period
Parkinson's Disease Questionnaire - 39 (PDQ39)
Time frame: 12month follow up period
Non-Motor Symptoms Scale (NMSS)
Time frame: 12month follow up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 9159723Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.
- Background: PubMed 23925954Schoneburg B, Mancini M, Horak F, Nutt JG. Framework for understanding balance dysfunction in Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1474-82. doi: 10.1002/mds.25613. Epub 2013 Aug 7.
- BackgroundGiladi N, Kao R, Fahn S. Freezing Phenomenon , the Fifth Cardinal Sign of Parkinsonism Freezing Phenomenon in Patients with Parkinsonian Syndromes. 2016;(January). doi:10.1007/978-1-4615-5337-3.
- Background: PubMed 22262741Espay AJ, Fasano A, van Nuenen BF, Payne MM, Snijders AH, Bloem BR. "On" state freezing of gait in Parkinson disease: a paradoxical levodopa-induced complication. Neurology. 2012 Feb 14;78(7):454-7. doi: 10.1212/WNL.0b013e3182477ec0. Epub 2012 Jan 18.
- Background: PubMed 26110808Fasano A, Lozano AM. Deep brain stimulation for movement disorders: 2015 and beyond. Curr Opin Neurol. 2015 Aug;28(4):423-36. doi: 10.1097/WCO.0000000000000226.
- Background: PubMed 21865071Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
- BackgroundSoltani F, Lalkhen A. Improvement of Parkinsonian Symptoms With Spinal Cord Stimulation: Consequence or Coincidence? J Neurol Neurosurg Psychiatry. 2013;84(11):e2.74-e2. doi:10.1136/jnnp-2013-306573.165.
- Background: PubMed 23453160Hassan S, Amer S, Alwaki A, Elborno A. A patient with Parkinson's disease benefits from spinal cord stimulation. J Clin Neurosci. 2013 Aug;20(8):1155-6. doi: 10.1016/j.jocn.2012.08.018. Epub 2013 Feb 26.
- Background: PubMed 27862267Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
- Background: PubMed 28681922Rohani M, Kalsi-Ryan S, Lozano AM, Fasano A. Spinal cord stimulation in primary progressive freezing of gait. Mov Disord. 2017 Sep;32(9):1336-1337. doi: 10.1002/mds.27103. Epub 2017 Jul 6. No abstract available.
- Background: PubMed 19127595Giladi N, Tal J, Azulay T, Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe WH, Stocchi F, Tolosa E. Validation of the freezing of gait questionnaire in patients with Parkinson's disease. Mov Disord. 2009 Apr 15;24(5):655-61. doi: 10.1002/mds.21745.
- Background: PubMed 16713924de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Nora Vanegas at 1 site in United States.
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 2 inclusion and 1 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 22 Feb 2024. 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 United States. 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?
Safety and Tolerability (time frame: 12-months). 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 NCT06272955, which also lists 42 linked publications.
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 22 Feb 2024.