Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorOregon Health and Science University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Repetitive transcranial magnetic stimulation (rTMS)
DeviceAim 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active TMS firstExperimental treatment 1 intervention
Group B: Sham treatment firstExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
objective posturography
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 periodSecondary outcomes
1
fNIRS
functional near infrared spectroscopy of premotor and motor areas during balance testing
Time frame
assessed on 4 days during the 8 week study period2
speech analysis
speech sample assessment conducted by investigator
Time frame
assessed on 4 days during the 8 week study periodSponsors and contacts
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Oregon Health and Science University
Lead sponsor
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
Source ClinicalTrials.gov