Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)

NCT05509842 | Not Yet Recruiting FDA Device

• 1 other identifier: HUM00212090
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson disease (PD) is a common disorder in which reduced speed of movement results from inadequate brain production of the chemical dopamine. The most effective treatment for Parkinson disease is the use of drugs that provide dopamine replacement therapy (DRT). However, as the disease progresses there are prominent DRT-resistant features of Parkinson disease that are a major source of disability. These include cognitive (attention, memory) impairments and gait disorders such as freezing and falls. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, holds promise for the study and treatment of motor and cognitive deficits in persons with Parkinson's. To date, there are no conclusive results regarding an optimal rTMS protocol for recovery of motor and cognitive deficits in Parkinson's disease. This study is designed to promote clinical rehabilitation neuroscience research, and aims to improve rehabilitation in persons with Parkinson's with freezing of gait. This work will evaluate the use of a new accelerated, high dose, non-invasive brain stimulation method for treatment of freezing of gait in PD and will test how applying targeted accelerated stimulation to the brain improves gait disturbance due to PD.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• Participant perception of treatment acceptability

  A study-specific questionnaire of rTMS treatment acceptability. Participants rate any perceived symptoms on a scale from 1 to 4 (none, mild, moderate, severe), with lower scores indicating better acceptability.

  up to six treatment days

• Retention rate

  Percentage of participants enrolled who completed the study.

  Change from Baseline prior to treatment and at follow-up within 1 week post-treatment

• Percentage change in TUG test time to 48 hours and 14 days post-intervention

  Time to complete the full TUG protocol.

  Change from Baseline; 48 hours post; 14 days post -intervention

• Net changes in FOG-Q scores at 48 hours and 14 days post-intervention

  Net changes in FOG-Q scores at 48 hours and 14 days post-intervention

  Change from Baseline; 48 hours post; 14 days post -intervention

Secondary Outcomes (2)

• Percentage change in accuracy to precision force-tracking task at 48 hours and 14 days post-intervention

  Baseline; 48 hours post; 14 days post -intervention

• Changes in functional connectivity and BOLD signal in the basal ganglia-cerebellar-cortical network during resting state and task-based fMRI 7-10 days post-intervention

  Baseline; 7-10 hours post-intervention

Study Arms (1)

Open label treatment

EXPERIMENTAL

All subjects then will receive open-label treatment (Tx) for six days within an fourteen-day span (Visits 3-8). Briefly, a newer form of rTMS called intermittent theta burst stimulation (iTBS) will be used that mimics endogenous theta rhythms, which can improve induction of synaptic long-term potentiation and influence functional connectivity. A 10-min iTBS sessions will be applied to the basal ganglia-cerebellar-cortical network immediately after the subject has primed and activated the network by performing a precision force tracking task for up to 10 min. The subject will undergo 5 sessions of the force task and stimulation per day, with each session separated by 40 min.

Device: rTMS

Interventions

rTMS DEVICE

A MagPro X100 magnetic stimulator with a 90mm figure-8 coil (MC-B70, MagVenture Inc.) will be used to apply rTMS to targeted locations marked on the structural MRI using a frameless infrared stereotactic neuronavigation system (Brainsight, Rogue Research).

Also known as: MagPro X100 magnetic stimulator with a 90mm figure-8 coil (MC-B70, MagVenture Inc.)

Open label treatment

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson disease (PD) with PD diagnosis based on the recent Movement Disorder Society criteria
• PD subjects \>45 years and \<90 will be studied
• H\&Y2-3 (early PD) subjects will be recruited
• English speaker
• Able to provide written consent prior to admission

You may not qualify if:

• The presence of other neurologic disease or neurologic findings on examination
• Depression: Geriatric Depression Scale (GDS) score \>11
• Evidence of a stroke or mass lesion on prior structural brain imaging (CT or MRI)
• Are younger than 45 or older than 90 years old
• Non-English speaker
• Are pregnant, suspect pregnancy or are attempting to become pregnant
• Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump
• Have cochlear hearing implants
• Are taking GABAergic, NDMA-receptor antagonist, or other drug known to influence neural receptors that facilitate neuroplasticity
• Have non removable body piercings or have foreign objects in body
• Have metal anywhere in the head that could increase a subjects risk of serious injury (not including braces, dental fillings, etc.):
• deep brain or vagus nerve stimulator
• aneurysm clips or coils
• stents in neck or brain
• implanted stimulators

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ashley Rettmann

CONTACT

734-763-2790; arettman@umich.edu

Michael Vesia, PhD

CONTACT

734-764-5237; mvesia@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Movement Science

Model Details: The proposed study is for an open-label trial in which participants will undergo up to 11 separate sessions, including a 6-day noninvasive brain stimulation intervention and basic neurological testing, neuroimaging, gait assessment, and cognitive/motor testing over a period of 4-6 weeks.

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)