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RecruitingNCT04468932Updated May 29, 2025

Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy

An interventional study of Repetitive transcranial magnetic stimulation (rTMS) in Palsy Supranuclear and Supranuclear Palsy, Progressive, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Palsy Supranuclear
  • Supranuclear Palsy, Progressive

Keywords

  • repetitive transcranial magnetic stimulation
03

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Active TMS first

    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.

    Device: Repetitive transcranial magnetic stimulation (rTMS)

  • Experimental
    Sham treatment first

    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.

    Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

  • DeviceRepetitive 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.

05

What researchers measure

Primary outcomes

  1. objective posturography

    The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.

    Time frame: assessed on 4 days during the 8 week study period

Secondary outcomes

  1. fNIRS

    functional near infrared spectroscopy of premotor and motor areas during balance testing

    Time frame: assessed on 4 days during the 8 week study period

  2. speech analysis

    speech sample assessment conducted by investigator

    Time frame: assessed on 4 days during the 8 week study period

06

Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04468932
Lead sponsor
Oregon Health and Science University
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
Marian L Dale, MD (Associate Professor of Neurology, School of Medicine; Director, OHSU CurePSP Center of Care, Oregon Health and Science University) — Principal investigator
First posted
Jul 13, 2020
Start date
Jan 17, 2020
Primary completion
Jan 6, 2027 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
May 29, 2025

Study contacts

Graham Harker
Contact
balance@ohsu.edu
5034182601
Marian L Dale, MD, MCR
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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