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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new, high-dose schedule of magnetic brain stimulation given without surgery. It is for people with Parkinson’s disease who have freezing of gait, when their feet seem stuck as they try to walk. Researchers want to see if this treatment improves walking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson’s disease diagnosed using Movement Disorder Society guidelines.
  • Be older than 45 and younger than 90.
  • Have early Parkinson’s disease, rated stage 2 or 3 on the Hoehn and Yahr scale.
  • Speak English.
  • Be able to give written consent before joining.

Who can't join

  • Have another brain or nerve disease, unusual findings on a nerve exam, or a depression screening score above 11.
  • Have had a stroke, brain bleeding, brain tumor, brain inflammation, multiple sclerosis, Alzheimer’s disease, or extra fluid or pressure in the brain.
  • Have attention deficit disorder, schizophrenia, bipolar disorder, diabetes treated with insulin, serious heart disease, or liver disease.
  • Are pregnant, think you may be pregnant, or are trying to become pregnant.
  • Have an implanted medical device, medicine pump, heart line, hearing implant, object in your body, or piercing that cannot be removed. Unsafe metal in or near the head also rules you out; braces and dental fillings do not.
  • Have a personal or family history of seizures, take drugs that raise seizure risk, or take certain drugs that affect how the brain changes and learns.
  • Have recently used recreational drugs or had heavy alcohol use, or have a history of alcohol or drug addiction.
  • Have jet lag from recent long air travel or are short on sleep.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Parkinson disease (PD) with PD diagnosis based on the recent Movement Disorder Society criteria 2. PD subjects \>45 years and \<90 will be studied 3. H\&Y2-3 (early PD) subjects will be recruited 4. English speaker 5. Able to provide written consent prior to admission Exclusion Criteria: 1. The presence of other neurologic disease or neurologic findings on examination 2. Depression: Geriatric Depression Scale (GDS) score \>11 3. Evidence of a stroke or mass lesion on prior structural brain imaging (CT or MRI) 4. Are younger than 45 or older than 90 years old 5. Non-English speaker 6. Are pregnant, suspect pregnancy or are attempting to become pregnant 7. Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump 8. Have cochlear hearing implants 9. Are taking GABAergic, NDMA-receptor antagonist, or other drug known to influence neural receptors that facilitate neuroplasticity 10. Have non removable body piercings or have foreign objects in body 11. Have metal anywhere in the head that could increase a subjects risk of serious injury (not including braces, dental fillings, etc.): 1. deep brain or vagus nerve stimulator 2. aneurysm clips or coils 3. stents in neck or brain 4. implanted stimulators 5. electrodes to monitor brain activity 6. metallic implants in eyes or ears 7. shrapnel or bullet fragments in or near the head 8. facial tattoos with metallic or magnetic-sensitive ink 9. other metal devices or objects implanted in or near the head, 12. Have any of the below conditions that would put a subject at increased risk of having a seizure: 1. a personal or family history of seizure/epilepsy 2. taking prescription drugs that lower the threshold for seizures 3. recent history of excessive alcohol consumption 4. history of alcohol addiction/dependence 5. recent history of recreational drug use 6. history of drug addiction/dependence 13. Have been diagnosed with any of the following: 1. A stroke, brain hemorrhage, brain tumor, encephalitis, or multiple sclerosis 2. Alzheimer's disease 3. attention deficit disorder, schizophrenia, or manic depressive (bipolar) disorder 4. normal pressure hydrocephalus or increased intra-cranial pressure 5. diabetes requiring insulin treatment 6. 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

Study sites (1)

MI