Clinical trial NCT04468932: Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
Official title: Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palsy Supranuclear
Supranuclear Palsy, Progressive
Keywords: repetitive transcranial magnetic stimulation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center of Neuromodulation for Rehabilitation
name: Collins Medical Trust
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Department of Health and Human Services
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: objective posturography
timeFrame: assessed on 4 days during the 8 week study period
Secondary outcomes:
measure: fNIRS
timeFrame: assessed on 4 days during the 8 week study period
measure: speech analysis
timeFrame: assessed on 4 days during the 8 week study period
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Marian L Dale, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References: