Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Supranuclear Palsy, Progressive; Palsy Supranuclear

Treatments: Device: Repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04468932

STUDY0020341

K23NS121402 (U.S. NIH Grant/Contract)

P2CHD086844 (U.S. NIH Grant/Contract)

KL2TR002370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Active TMS first

Experimental group

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.

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS)

Sham treatment first

Experimental group

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.

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS)