Palsy SupranuclearNCT04468932
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Palsy Supranuclear and Supranuclear Palsy, Progressive, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Palsy Supranuclear, Supranuclear Palsy, Progressive
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2020to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- probable or possible PSP by the revised MDS PSP Criteria (Hoglinger 2017)
- age 40-85 at time of screening
- ability to understand and cooperate with simple instructions in English
- ability to read at 6th grade reading level in English
- ability to stand unassisted for at least 30 seconds and to be able walk independently with a walker
- ability to refrain from new physical and speech therapy programs for the duration of the study
- ability to remain on stable doses of any cholinergic, dopaminergic, serotonergic sedative or NMDA receptor antagonists for the duration of the study
- females of child-bearing age must perform a urine pregnancy test and be on reliable birth control during the course of the study
Who cannot join
- other significant neurological or vestibular disorders
- presence of electrically, magnetically or mechanically activated implants or history of injurious metal exposure in eyes, head, or body
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Graham Harker, 503-418-2601, balance@ohsu.edu
About this study
Official title: Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy
The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). The central hypothesis is that augmenting cerebellar inhibition via cerebellar rTMS will decrease postural instability in patients with PSP. We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS.
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
Aim 1: To determine the clinical effects of rTMS targeting the cerebellum on postural instability in PSP. The hypothesis to be tested is that TMS augmentation of cerebellar inhibition will improve cerebellum-dependent balance symptoms of PSP for a period of time sufficient to improve rehabilitation outcomes. The investigators will measure a battery of objective posturography metrics and other measures of motor control, including sway and center of pressure changes to backward tilt and forward translation.
Aim 2: We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS. The hypothesis to be tested is that premotor and motor cortical activity will decrease after cerebellar rTMS compared to sham TMS, reflecting improved cerebellar inhibition of the motor cortex after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Active TMS first | Experimental | After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week TMS intervention. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week sham TMS period prior to their final assessment. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Sham treatment first | Experimental | After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week sham TMS period. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week TMS intervention prior to their final assessment. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective posturography
The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.
Measured: assessed on 4 days during the 8 week study period
Secondary outcomes (2)
fNIRS
functional near infrared spectroscopy of premotor and motor areas during balance testing
Measured: assessed on 4 days during the 8 week study period
speech analysis
speech sample assessment conducted by investigator
Measured: assessed on 4 days during the 8 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start17 Jan 2020
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palsy SupranuclearStudies 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
- Model description
- The investigators will use a single-blind crossover design with a 4 week TMS washout period. The subjects will serve as their own controls, thus limiting confounding variables such as medication or cognitive effect.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation, Collins Medical Trust, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Department of Health and Human Services, National Institute of Neurological Disorders and Stroke (NINDS), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Marian L Dale, MD, Oregon Health and Science University
- Investigators
- Marian L Dale, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468932
- Sponsor's protocol ID
- STUDY0020341
- Other IDs
- KL2TR002370, P2CHD086844, K23NS121402
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy
- ClinicalTrials.gov ID
- NCT04468932
- Acronym / sponsor ID
- STUDY0020341
- Keywords
- repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center of Neuromodulation for Rehabilitation, Collins Medical Trust, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Department of Health and Human Services, National Institute of Neurological Disorders and Stroke (NINDS), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Jul 2020 (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.
The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). The central hypothesis is that augmenting cerebellar inhibition via cerebellar rTMS will decrease postural instability in patients with PSP. We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will use a single-blind crossover design with a 4 week TMS washout period. The subjects will serve as their own controls, thus limiting confounding variables such as medication or cognitive effect.
| Arm | Type | Receives |
|---|---|---|
| Active TMS first | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week TMS intervention. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week sham TMS period prior to their final assessment. |
| Sham treatment first | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week sham TMS period. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week TMS intervention prior to their final assessment. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- probable or possible PSP by the revised MDS PSP Criteria (Hoglinger 2017)
- age 40-85 at time of screening
- ability to understand and cooperate with simple instructions in English
- ability to read at 6th grade reading level in English
- ability to stand unassisted for at least 30 seconds and to be able walk independently with a walker
Key exclusion criteria (2 listed)
- other significant neurological or vestibular disorders
- presence of electrically, magnetically or mechanically activated implants or history of injurious metal exposure in eyes, head, or body
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)Aim 1: To determine the clinical effects of rTMS targeting the cerebellum on postural instability in PSP. The hypothesis to be tested is that TMS augmentation of cerebellar inhibition will improve cerebellum-dependent balance symptoms of PSP for a period of time sufficient to improve rehabilitation outcomes. The investigators will measure a battery of objective posturography metrics and other measures of motor control, including sway and center of pressure changes to backward tilt and forward translation. Aim 2: We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS. The hypothesis to be tested is that premotor and motor cortical activity will decrease after cerebellar rTMS compared to sham TMS, reflecting improved cerebellar inhibition of the motor cortex after the intervention. | Device | Active TMS first, Sham treatment first |
Primary outcome
objective posturography
Time frame: assessed on 4 days during the 8 week study period
The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.
2 secondary outcomes
fNIRS
Time frame: assessed on 4 days during the 8 week study period
speech analysis
Time frame: assessed on 4 days during the 8 week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
Marian L Dale, MD, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Palsy Supranuclear and Supranuclear Palsy, Progressive, run by Oregon Health and Science University 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graham Harker (5034182601, balance@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective posturography (time frame: assessed on 4 days during the 8 week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.