Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy

Not Applicable

Recruiting

• Conditions: Supranuclear Palsy, Progressive; Palsy Supranuclear
• Interventions: Device: Repetitive transcranial magnetic stimulation (rTMS)

• Registration Number: NCT04468932
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-17
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2027-01-06
• Study Completion: 2027-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active TMS first	Repetitive transcranial magnetic stimulation (rTMS)	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.
Sham treatment first	Repetitive transcranial magnetic stimulation (rTMS)	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.

Primary Outcome Measures

Name	Time	Method
objective posturography	assessed on 4 days during the 8 week study period	The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.

Secondary Outcome Measures

Name	Time	Method
fNIRS	assessed on 4 days during the 8 week study period	functional near infrared spectroscopy of premotor and motor areas during balance testing
speech analysis	assessed on 4 days during the 8 week study period	speech sample assessment conducted by investigator

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States