Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy

NCT04468932 | Recruiting DMC FDA Device

• 4 other identifiers: STUDY0020341KL2TR002370P2CHD086844K23NS121402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palsy Supranuclear; Supranuclear Palsy, Progressive

Keywords

repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• objective posturography

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

  assessed on 4 days during the 8 week study period

Secondary Outcomes (2)

• fNIRS

  assessed on 4 days during the 8 week study period

• speech analysis

  assessed on 4 days during the 8 week study period

Study Arms (2)

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.

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.

Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

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.

Active TMS first; Sham treatment first

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Marian L Dale, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graham Harker

CONTACT

5034182601; balance@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The subjects will be blinded to the order of intervention, but the PI will not be blinded in order to perform the TMS intervention. The outcome evaluators will be blinded to the intervention, however.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, School of Medicine; Director, OHSU CurePSP Center of Care

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: January 17, 2020
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)