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Non-invasive Brain Stimulation

rTMS for Progressive Supranuclear Palsy

N/A

Recruiting

Led By Marian L Dale, MD, MCR

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to refrain from new physical and speech therapy programs for the duration of the study

Age 40-85 at time of screening

Must not have

Other significant neurological or vestibular disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed on 4 days during the 8 week study period

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether non-invasive brain stimulation can improve motor control in people with a degenerative brain disease.

Who is the study for?

This trial is for adults aged 40-85 with progressive supranuclear palsy (PSP) who can follow simple instructions and walk independently with a walker. They must not start new therapies during the study, be on stable medication doses, and women of childbearing age need to use reliable birth control.

What is being tested?

The trial tests if non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) can improve motor control in PSP patients by targeting the cerebellum. Changes in brain activity will be monitored using functional near infrared spectroscopy (fNIRS).

What are the potential side effects?

Potential side effects of rTMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however, these are generally rare and rTMS is considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can avoid starting new physical or speech therapy during the study.

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I am between 40 and 85 years old.

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I can stand by myself for at least 30 seconds and walk with a walker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major nerve or balance disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed on 4 days during the 8 week study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed on 4 days during the 8 week study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed on 4 days during the 8 week study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

objective posturography

Secondary study objectives

fNIRS

speech analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham treatment firstExperimental Treatment1 Intervention

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.

Group II: Active TMS firstExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive transcranial magnetic stimulation (rTMS)

2021

Completed Phase 4

~730

0 / 4Eligibility criteria met