Progressive Supranuclear PalsyNCT01174771
Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration
An observational study of Progressive Supranuclear Palsy and Corticobasal Degeneration, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal 1. Therefore, there is an urgent need to find alternative therapies to treat atypical parkinsonian disorders. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy, Corticobasal Degeneration, Parkinsonism
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2012
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The purpose of this study is to learn more about how transcranial magnetic stimulation (TMS) affects motor and non-motor function in patients with Progressive Supranuclear Palsy (PSP) or Cortical Basal Ganglionic Degeneration (CBGD)-forms of parkinsonism.
Who may be able to join
- If you are an adult with PSP or CBGD:
- 1. Must be in good physical health.
- If you are neurologically healthy volunteers:
- 1. Must be older than 35 years
Who cannot join
- Must have no implanted metal. Dental fillings are acceptable.
- Must have no personal seizure or 1st degree relative with history of seizures
- Must not take any medication that lowers seizure threshold.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Cortical Stimulation (rTMS) for Motor and Non-Motor Features of Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBD)
Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal 1. Therefore, there is an urgent need to find alternative therapies to treat atypical parkinsonian disorders. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive tool that modulates cortical excitability with minimal discomfort and holds therapeutic promise in treating neurological and psychiatric disorders.
The basal ganglia-thalamocortical circuits that are affected in Progressive Supranuclear Palsy (PSP) and Corticocbasal Ganglionic Degeneration (CBGD) are likely structurally and functionally segregated. The 'motor' circuit is implicated in parkinsonian akinesia and hypokinesia; a 'prefrontal' circuit is implicated in working memory and mood regulation, and linked with non-motor symptoms such as depression and apathy. In this proposal, we characterize motor and prefrontal network dysfunction in PSP and CBGD patients, and propose that high-frequency and low-frequency rTMS directed over separate motor and prefrontal cortical targets of each network may show specific and selective beneficial effects on motor vs. cognitive function in PSP and CBGD patients, respectively. Quantitative motor outcome measures include timed finger tapping tasks. Quantitative cognitive outcome measures comprise a visual analogue scale (VAS).
If successful, this pilot study will provide proof of principle data to suggest potential benefits for rTMS in PSP/CBGD patients, and provide sufficient data and experience to support future PSP/CBGD studies that include the use of rTMS to investigate the pathophysiology of motor and non-motor features of PSP and CBGD patients.
Read the detailed description
Background: Drug therapy of atypical parkinsonism is generally ineffective or minimal, and novel therapy approaches for atypical parkinsonian disorders are needed. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive tool that modulates cortical excitability and holds promise in treating neurological/psychiatric disorders. The 'motor' basal ganglia-cortical circuit is implicated in parkinsonian akinesia and hypokinesia; a 'prefrontal' circuit is implicated in working memory (WM) and mood regulation, possibly linked to depression and apathy.
Hypothesis: Motor deficits in Progressive Supranuclear Palsy (PSP) and Corticobasal Ganglionic Degeneration (CBGD) are associated with a dysfunctional motor network; emotional deficits in PSP/CBGD are associated with a dysfunctional prefrontal network. We hypothesize that high-frequency and low-frequency rTMS over cortical targets will selectively and specifically improve tasks and symptoms relevant to that target in PSP and CBGD patients, respectively.
Aims: To contrast cortical excitability characteristics and motor and emotional function between PSP and CBGD patients. To determine selective and specific beneficial rTMS effects over primary motor (M1) and dorsolateral prefrontal (DLPFC) cortex on cortical excitability characteristics and motor and emotional function in PSP and CBGD patients.
Design: Ten individuals with PSP and ten with CBGD will participate in a within-subject cross-sectional design. Motor outcome measures include a timed finger tapping task at comfortable and maximal speed. Quantitative cognitive outcome measures comprise a visual analogue scale of mood states (VAS). After a first baseline visit, PSP patients will receive high-frequency 5 Hz rTMS in two separate visits to two site conditions (left DLPFC vs. the more affected side of M1) across subjects with two within-session task conditions (motor vs. cognitive). They will also receive sham stimulation in a separate visit. These three stimulation visits will be randomized. CBGD patients will receive the same treatment with the only difference that they will receive low-frequency 1 Hz rTMS instead.
Relevance: If successful, we will demonstrate a double-dissociation and causal functional significance between rTMS modulation of M1 in motor tasks and DLPFC in emotional function in PSP Vs. CBGD. Exploratory aims will be conducted. Sufficient data and experience for future PSP/CBGD intervention studies will help identify candidate TMS parameters that are optimal for given symptoms.
- Keywords
- Transcranial magnetic stimulation, Cortical excitability, parkinsonism, Progressive Supranuclear Palsy, Corticobasal Degeneration, PSP, CBD, CBGD
- Medical subject headings
- Supranuclear Palsy, Progressive, Corticobasal Degeneration, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSP patients | People that have been clinically diagnosed with atypical parkinsonism, i.e., PSP | |
| CBD patients | People that have been clinically diagnosed with atypical parkinsonism, i.e., CBD | |
| Age-matched healthy controls | People that have not been diagnosed with any kind of neurologic movement disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability (CE) measures expressed in motor evoked potentials (MEP)
We assess cortical excitability (CE) with motor evoked potentials (MEP) and cortical silent periods (CSP) before and after repetitive Transcranial Magnetic Stimulation (TMS).
Measured: 1 hour
Secondary outcomes (2)
visual analog scale (VAS)
We assess mood with a visual analog scale (VAS) of 5 emotions and 1 overall feeling of well-being.
Measured: 2 min
tapping speed
tapping speed (movement time and reaction time) will be measured
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi Deblieck, University of California, Los Angeles
- Investigators
- Allan Wu, M.D., Principal investigator, UCLA Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174771
- Sponsor's protocol ID
- UCaliforniaLA
- Other IDs
- CurePSP
- Status last verified
- May 2014
- First submitted
- 28 Jul 2010
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
PubMed 1695401Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
PubMed 8684201Siebner HR, Rossmeier C, Mentschel C, Peinemann A, Conrad B. Short-term motor improvement after sub-threshold 5-Hz repetitive transcranial magnetic stimulation of the primary motor hand area in Parkinson's disease. J Neurol Sci. 2000 Sep 15;178(2):91-4. doi: 10.1016/s0022-510x(00)00370-1.
PubMed 11018700Lang P. The international affective picture system [photographic slides]. Technical report. Gainsville, FL: The Center for Research in Phycophysiology, University of Florida; 1988.
Tumas V, Rodrigues GG, Farias TL, Crippa JA. The accuracy of diagnosis of major depression in patients with Parkinson's disease: a comparative study among the UPDRS, the geriatric depression scale and the Beck depression inventory. Arq Neuropsiquiatr. 2008 Jun;66(2A):152-6. doi: 10.1590/s0004-282x2008000200002.
PubMed 18545773Filipovic SR, Rothwell JC, van de Warrenburg BP, Bhatia K. Repetitive transcranial magnetic stimulation for levodopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):246-53. doi: 10.1002/mds.22348.
PubMed 18951540Murase N, Rothwell JC, Kaji R, Urushihara R, Nakamura K, Murayama N, Igasaki T, Sakata-Igasaki M, Mima T, Ikeda A, Shibasaki H. Subthreshold low-frequency repetitive transcranial magnetic stimulation over the premotor cortex modulates writer's cramp. Brain. 2005 Jan;128(Pt 1):104-15. doi: 10.1093/brain/awh315. Epub 2004 Oct 13.
PubMed 15483042Lefaucheur JP, Fenelon G, Menard-Lefaucheur I, Wendling S, Nguyen JP. Low-frequency repetitive TMS of premotor cortex can reduce painful axial spasms in generalized secondary dystonia: a pilot study of three patients. Neurophysiol Clin. 2004 Oct;34(3-4):141-5. doi: 10.1016/j.neucli.2004.07.003.
PubMed 15501683Siebner HR, Mentschel C, Auer C, Conrad B. Repetitive transcranial magnetic stimulation has a beneficial effect on bradykinesia in Parkinson's disease. Neuroreport. 1999 Feb 25;10(3):589-94. doi: 10.1097/00001756-199902250-00027.
PubMed 10208595Khedr EM, Farweez HM, Islam H. Therapeutic effect of repetitive transcranial magnetic stimulation on motor function in Parkinson's disease patients. Eur J Neurol. 2003 Sep;10(5):567-72. doi: 10.1046/j.1468-1331.2003.00649.x.
PubMed 12940840Lefaucheur JP, Drouot X, Von Raison F, Menard-Lefaucheur I, Cesaro P, Nguyen JP. Improvement of motor performance and modulation of cortical excitability by repetitive transcranial magnetic stimulation of the motor cortex in Parkinson's disease. Clin Neurophysiol. 2004 Nov;115(11):2530-41. doi: 10.1016/j.clinph.2004.05.025.
PubMed 15465443Stern WM, Tormos JM, Press DZ, Pearlman C, Pascual-Leone A. Antidepressant effects of high and low frequency repetitive transcranial magnetic stimulation to the dorsolateral prefrontal cortex: a double-blind, randomized, placebo-controlled trial. J Neuropsychiatry Clin Neurosci. 2007 Spring;19(2):179-86. doi: 10.1176/jnp.2007.19.2.179.
PubMed 17431065Rektorova I, Sedlackova S, Telecka S, Hlubocky A, Rektor I. Dorsolateral prefrontal cortex: a possible target for modulating dyskinesias in Parkinson's disease by repetitive transcranial magnetic stimulation. Int J Biomed Imaging. 2008;2008:372125. doi: 10.1155/2008/372125.
PubMed 18274665Epstein CM, Evatt ML, Funk A, Girard-Siqueira L, Lupei N, Slaughter L, Athar S, Green J, McDonald W, DeLong MR. An open study of repetitive transcranial magnetic stimulation in treatment-resistant depression with Parkinson's disease. Clin Neurophysiol. 2007 Oct;118(10):2189-94. doi: 10.1016/j.clinph.2007.07.010. Epub 2007 Aug 21.
PubMed 17714987
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Cortical Stimulation (rTMS) for Motor and Non-Motor Features of Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBD)
- ClinicalTrials.gov ID
- NCT01174771
- Acronym / sponsor ID
- UCaliforniaLA
- Keywords
- Transcranial magnetic stimulation, Cortical excitability, parkinsonism, Progressive Supranuclear Palsy, Corticobasal Degeneration, PSP, CBD, CBGD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Aug 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.
Drug therapy of atypical parkinsonism is generally considered either ineffective or minimal 1. Therefore, there is an urgent need to find alternative therapies to treat atypical parkinsonian disorders. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive tool that modulates cortical excitability with minimal discomfort and holds therapeutic promise in treating neurological and psychiatric disorders.
The basal ganglia-thalamocortical circuits that are affected in Progressive Supranuclear Palsy (PSP) and Corticocbasal Ganglionic Degeneration (CBGD) are likely structurally and functionally segregated. The 'motor' circuit is implicated in parkinsonian akinesia and hypokinesia; a 'prefrontal' circuit is implicated in working memory and mood regulation, and linked with non-motor symptoms such as depression and apathy. In this proposal, we characterize motor and prefrontal network dysfunction in PSP and CBGD patients, and propose that high-frequency and low-frequency rTMS directed over separate motor and prefrontal cortical targets of each network may show specific and selective beneficial effects on motor vs. cognitive function in PSP and CBGD patients, respectively. Quantitative motor outcome measures include timed finger tapping tasks. Quantitative cognitive outcome measures comprise a visual analogue scale (VAS).
If successful, this pilot study will provide proof of principle data to suggest potential benefits for rTMS in PSP/CBGD patients, and provide sufficient data and experience to support future PSP/CBGD studies that include the use of rTMS to investigate the pathophysiology of motor and non-motor features of PSP and CBGD patients.
Detailed description
Background: Drug therapy of atypical parkinsonism is generally ineffective or minimal, and novel therapy approaches for atypical parkinsonian disorders are needed. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive tool that modulates cortical excitability and holds promise in treating neurological/psychiatric disorders. The 'motor' basal ganglia-cortical circuit is implicated in parkinsonian akinesia and hypokinesia; a 'prefrontal' circuit is implicated in working memory (WM) and mood regulation, possibly linked to depression and apathy.
Hypothesis: Motor deficits in Progressive Supranuclear Palsy (PSP) and Corticobasal Ganglionic Degeneration (CBGD) are associated with a dysfunctional motor network; emotional deficits in PSP/CBGD are associated with a dysfunctional prefrontal network. We hypothesize that high-frequency and low-frequency rTMS over cortical targets will selectively and specifically improve tasks and symptoms relevant to that target in PSP and CBGD patients, respectively.
Aims: To contrast cortical excitability characteristics and motor and emotional function between PSP and CBGD patients. To determine selective and specific beneficial rTMS effects over primary motor (M1) and dorsolateral prefrontal (DLPFC) cortex on cortical excitability characteristics and motor and emotional function in PSP and CBGD patients.
Design: Ten individuals with PSP and ten with CBGD will participate in a within-subject cross-sectional design. Motor outcome measures include a timed finger tapping task at comfortable and maximal speed. Quantitative cognitive outcome measures comprise a visual analogue scale of mood states (VAS). After a first baseline visit, PSP patients will receive high-frequency 5 Hz rTMS in two separate visits to two site conditions (left DLPFC vs. the more affected side of M1) across subjects with two within-session task conditions (motor vs. cognitive). They will also receive sham stimulation in a separate visit. These three stimulation visits will be randomized. CBGD patients will receive the same treatment with the only difference that they will receive low-frequency 1 Hz rTMS instead.
Relevance: If successful, we will demonstrate a double-dissociation and causal functional significance between rTMS modulation of M1 in motor tasks and DLPFC in emotional function in PSP Vs. CBGD. Exploratory aims will be conducted. Sufficient data and experience for future PSP/CBGD intervention studies will help identify candidate TMS parameters that are optimal for given symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSP patients | – | –People that have been clinically diagnosed with atypical parkinsonism, i.e., PSP |
| CBD patients | – | –People that have been clinically diagnosed with atypical parkinsonism, i.e., CBD |
| Age-matched healthy controls | – | –People that have not been diagnosed with any kind of neurologic movement disorder. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The purpose of this study is to learn more about how transcranial magnetic stimulation (TMS) affects motor and non-motor function in patients with Progressive Supranuclear Palsy (PSP) or Cortical Basal Ganglionic Degeneration (CBGD)-forms of parkinsonism.
Key inclusion criteria (4 listed)
- 1. Must be in good physical health.
- 1. Must be older than 35 years
Key exclusion criteria (3 listed)
- Must have no implanted metal. Dental fillings are acceptable.
- Must have no personal seizure or 1st degree relative with history of seizures
- Must not take any medication that lowers seizure threshold.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cortical excitability (CE) measures expressed in motor evoked potentials (MEP)
Time frame: 1 hour
We assess cortical excitability (CE) with motor evoked potentials (MEP) and cortical silent periods (CSP) before and after repetitive Transcranial Magnetic Stimulation (TMS).
2 secondary outcomes
visual analog scale (VAS)
Time frame: 2 min
tapping speed
Time frame: 5 min
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 8 May 2014.
- Background: PubMed 1695401Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
- Background: PubMed 8684201Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
- Background: PubMed 11018700Siebner HR, Rossmeier C, Mentschel C, Peinemann A, Conrad B. Short-term motor improvement after sub-threshold 5-Hz repetitive transcranial magnetic stimulation of the primary motor hand area in Parkinson's disease. J Neurol Sci. 2000 Sep 15;178(2):91-4. doi: 10.1016/s0022-510x(00)00370-1.
- BackgroundLang P. The international affective picture system [photographic slides]. Technical report. Gainsville, FL: The Center for Research in Phycophysiology, University of Florida; 1988.
- Background: PubMed 18545773Tumas V, Rodrigues GG, Farias TL, Crippa JA. The accuracy of diagnosis of major depression in patients with Parkinson's disease: a comparative study among the UPDRS, the geriatric depression scale and the Beck depression inventory. Arq Neuropsiquiatr. 2008 Jun;66(2A):152-6. doi: 10.1590/s0004-282x2008000200002.
- Background: PubMed 18951540Filipovic SR, Rothwell JC, van de Warrenburg BP, Bhatia K. Repetitive transcranial magnetic stimulation for levodopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):246-53. doi: 10.1002/mds.22348.
- Background: PubMed 15483042Murase N, Rothwell JC, Kaji R, Urushihara R, Nakamura K, Murayama N, Igasaki T, Sakata-Igasaki M, Mima T, Ikeda A, Shibasaki H. Subthreshold low-frequency repetitive transcranial magnetic stimulation over the premotor cortex modulates writer's cramp. Brain. 2005 Jan;128(Pt 1):104-15. doi: 10.1093/brain/awh315. Epub 2004 Oct 13.
- Background: PubMed 15501683Lefaucheur JP, Fenelon G, Menard-Lefaucheur I, Wendling S, Nguyen JP. Low-frequency repetitive TMS of premotor cortex can reduce painful axial spasms in generalized secondary dystonia: a pilot study of three patients. Neurophysiol Clin. 2004 Oct;34(3-4):141-5. doi: 10.1016/j.neucli.2004.07.003.
- Background: PubMed 10208595Siebner HR, Mentschel C, Auer C, Conrad B. Repetitive transcranial magnetic stimulation has a beneficial effect on bradykinesia in Parkinson's disease. Neuroreport. 1999 Feb 25;10(3):589-94. doi: 10.1097/00001756-199902250-00027.
- Background: PubMed 12940840Khedr EM, Farweez HM, Islam H. Therapeutic effect of repetitive transcranial magnetic stimulation on motor function in Parkinson's disease patients. Eur J Neurol. 2003 Sep;10(5):567-72. doi: 10.1046/j.1468-1331.2003.00649.x.
- Background: PubMed 15465443Lefaucheur JP, Drouot X, Von Raison F, Menard-Lefaucheur I, Cesaro P, Nguyen JP. Improvement of motor performance and modulation of cortical excitability by repetitive transcranial magnetic stimulation of the motor cortex in Parkinson's disease. Clin Neurophysiol. 2004 Nov;115(11):2530-41. doi: 10.1016/j.clinph.2004.05.025.
- Background: PubMed 17431065Stern WM, Tormos JM, Press DZ, Pearlman C, Pascual-Leone A. Antidepressant effects of high and low frequency repetitive transcranial magnetic stimulation to the dorsolateral prefrontal cortex: a double-blind, randomized, placebo-controlled trial. J Neuropsychiatry Clin Neurosci. 2007 Spring;19(2):179-86. doi: 10.1176/jnp.2007.19.2.179.
Related trials for Progressive Supranuclear Palsy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
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.
Allan Wu, M.D. principal investigator
UCLA Neurology
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 Progressive Supranuclear Palsy and Corticobasal Degeneration, run by University of California, Los Angeles 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 4 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: finished, as of the sponsor's last update on 8 May 2014. 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?
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?
Cortical excitability (CE) measures expressed in motor evoked potentials (MEP) (time frame: 1 hour). 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 NCT01174771, which also lists 14 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 8 May 2014.