Back to resultsTranscranial Magnetic Stimulation in Progressive Supranuclear Palsy
Primary Purpose
Palsy Supranuclear, Supranuclear Palsy, Progressive
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Palsy Supranuclear focused on measuring repetitive transcranial magnetic stimulation
Eligibility Criteria
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
Sites / Locations
- Oregon Health & Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Active TMS first
Sham treatment first
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
objective posturography
The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.
Secondary Outcome Measures
fNIRS
functional near infrared spectroscopy of premotor and motor areas during balance testing
speech analysis
speech sample assessment conducted by investigator
Full Information
NCT ID
NCT04468932
First Posted
July 7, 2020
Last Updated
April 24, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT04468932
Brief Title
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
Official Title
Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palsy Supranuclear, Supranuclear Palsy, Progressive
Keywords
repetitive transcranial magnetic stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active TMS first
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham treatment first
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
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 Outcome Measure Information:
Title
objective posturography
Description
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 Outcome Measure Information:
Title
fNIRS
Description
functional near infrared spectroscopy of premotor and motor areas during balance testing
Time Frame
assessed on 4 days during the 8 week study period
Title
speech analysis
Description
speech sample assessment conducted by investigator
Time Frame
assessed on 4 days during the 8 week study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Graham Harker
Phone
5034182601
Email
balance@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian L Dale, MD, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Harker
Phone
503-418-2601
Email
balance@ohsu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
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