NCT05509842Not yet recruiting
Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
High-dose Accelerated Theta Burst Stimulation to Restore PD-induced Motor Network Dysconnectivity
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Aug 2022
- Start date
- 1 Sept 2027
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- University of Michigan
- Diseases
- Parkinson disease
- NCT number
- NCT05509842
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Sept 2027 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of a stroke or mass lesion on prior structural brain imaging (CT or MRI)
- Have cochlear hearing implants
- Are taking GABAergic, NDMA-receptor antagonist, or other drug known to influence neural receptors that facilitate neuroplasticity
- 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
- electrodes to monitor brain activity
- metallic implants in eyes or ears
- shrapnel or bullet fragments in or near the head
- facial tattoos with metallic or magnetic-sensitive ink
- other metal devices or objects implanted in or near the head,
Other illness
- The presence of other neurologic disease or neurologic findings on examination
- Have any of the below conditions that would put a subject at increased risk of having a seizure:
- a personal or family history of seizure/epilepsy
- taking prescription drugs that lower the threshold for seizures
- recent history of excessive alcohol consumption
- history of alcohol addiction/dependence
- recent history of recreational drug use
- history of drug addiction/dependence
- Have been diagnosed with any of the following:
- A stroke, brain hemorrhage, brain tumor, encephalitis, or multiple sclerosis
- Alzheimer's disease
- attention deficit disorder, schizophrenia, or manic depressive (bipolar) disorder
- normal pressure hydrocephalus or increased intra-cranial pressure
- diabetes requiring insulin treatment
- any serious heart disorder or liver disease
- 6\. Metallic medical implants (i.e. pacemaker), foreign objects in body, non-removable body-piercings 7. Pregnancy 8. Additional exclusion criteria related to TMS: g. Metal in the cranium (mouth excluded) h. Cardiac pacemaker i. Implanted medication pump j. Implanted deep brain stimulator or vagus nerve stimulator k. Intracardiac lines l. Serious heart disease m. Increased intracranial pressure n. History of seizures o. Epileptogenic medication p. Cochlear implants q. Recent extended air travel resulting in jetlag or other sleep deprived state
Age
- Are younger than 45 or older than 90 years old
Other
- Depression: Geriatric Depression Scale (GDS) score \>11
- 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 non removable body piercings or have foreign objects in body
Who the study is looking for
- 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
Age in the registry: 45 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.