Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy

Supranuclear Palsy, Progressive Clinical Trial

Official title:

Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04468932
• Other study ID #: STUDY0020341
• Secondary ID: KL2TR002370P2CHD
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: April 20, 2027

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Graham Harker
• Phone: 5034182601
• Email: balance[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 20, 2027
• Est. primary completion date: January 6, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Palsy Supranuclear
• Paralysis
• Supranuclear Palsy, Progressive

Intervention

Device:
• Repetitive transcranial magnetic stimulation (rTMS)
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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (8)

Lead Sponsor	Collaborator
Oregon Health and Science University	Collins Medical Trust, Department of Health and Human Services, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS), National Center of Neuromodulation for Rehabilitation, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective posturography	The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.	assessed on 4 days during the 8 week study period
Secondary	fNIRS	functional near infrared spectroscopy of premotor and motor areas during balance testing	assessed on 4 days during the 8 week study period
Secondary	speech analysis	speech sample assessment conducted by investigator	assessed on 4 days during the 8 week study period