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NCT Number: NCT04468932

Transcranial Magnetic Stimulation 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.

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Key information

Conditions

Palsy Supranuclear Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Graham Harker

CONTACT

[email protected]

5034182601

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. fNIRS

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

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

  2. speech analysis

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

    speech sample assessment conducted by investigator

Study contacts

Contact information is provided by the study sponsor or research team.

Graham Harker

CONTACT

[email protected]

5034182601

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Collins Medical Trust
  • Department of Health and Human Services
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Advancing Translational Sciences (NCATS)
  • National Center of Neuromodulation for Rehabilitation
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2020
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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