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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed on 4 days during the 8 week study period
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
I can avoid starting new physical or speech therapy during the study.
Select...
I am between 40 and 85 years old.
Select...
I can stand by myself for at least 30 seconds and walk with a walker.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
objective posturography
Secondary outcome measures
fNIRS
speech analysis
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)
2017
Completed Phase 4
~700
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,882 Total Patients Enrolled
National Center of Neuromodulation for RehabilitationOTHER
10 Previous Clinical Trials
201 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,329 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can keep my current doses of brain-related medications stable during the study.I can avoid starting new physical or speech therapy during the study.I am using reliable birth control and will take a pregnancy test if I can have children.I do not have major nerve or balance disorders.I am between 40 and 85 years old.You may have a condition called probable or possible progressive supranuclear palsy, as determined by specific criteria from 2017.You have any electronic, magnetic, or mechanical implants, or have had metal in your eyes, head, or body that could cause harm.I can stand by myself for at least 30 seconds and walk with a walker.
Research Study Groups:
This trial has the following groups:- Group 1: Active TMS first
- Group 2: Sham treatment first
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the current recruitment for this particular experiment?
"Affirmative. According to the clinicaltrials.gov database, this trial is still accepting patients after its posting on January 17th 2020 and last edit on May 11th 2022. 30 participants need to be enrolled for this study at one location."
Answered by AI
Are there still openings available for participants in this research project?
"Affirmative. Evidenced by the records on clinicaltrials.gov, this investigation is still actively recruiting participants since its inception in January 17th 2020 and latest update on May 11th 2022."
Answered by AI
What criteria must individuals meet in order to participate in this experiment?
"This scientific investigation is looking for 30 individuals with supranuclear palsy, progressive aged 40 to 85. Criteria that applicants must meet include the following: age between 40 and 85 at screening time; comprehension of simple instructions in English and reading ability equivalent to a 6th grader in English; lack of changes in cholinergic, dopaminergic, serotonergic sedative or NMDA receptor antagonist regimens during the trial period; women within childbearing years who shall take a urine pregnancy test and use reliable contraception methods throughout the study duration; probable or possible PSP as per MDS PSP Criteria (Hoglinger 2017);"
Answered by AI
Does the experiment accept participants under 85 years of age?
"This study is recruiting individuals 40 years or older and not exceeding the age of 85."
Answered by AI
Who else is applying?
What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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