Parkinson DiseaseNCT05509842
Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
A study testing rTMS in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2027to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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
- 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,
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109
Ashley Rettmann, 734-763-2790, ashley.rettmann@gmail.com
Michael Vesia, PhD
About this study
Official title: High-dose Accelerated Theta Burst Stimulation to Restore PD-induced Motor Network Dysconnectivity
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.
Read the detailed description
- The proposed research will characterize how inter-individual brain and behavior differences (i.e., gait function behavior and fMRI functional connectivity) at baseline relate to the treatment response.
- This knowledge will provide important information about how interventions can be personalized and optimized.
- The work may increase understanding of the underlying neurobiological mechanisms of neuromodulation for rehabilitation in patients with gait disturbances due to PD.
- Impact: Results will provide insights into the effects of the neuromodulatory treatment on gait and motor dysfunction and could dramatically improve quality of life for patients with PD. The results also will (1) provide a mechanistic foundation for studies of therapeutic iTBS for PD patients, (2) evaluate novel stimulation targets, and (3) markedly condense the duration of treatment into a more manageable timeframe for patients.
Our overall objectives in the current study are to:
- To establish safety, feasibility, and tolerability of a high-dose, resting-state functional connectivity-guided iTBS
- To elucidate the neural mechanism by which such a highly efficient and personalized stimulation approach leads to improvements in freezing of gait in PD.
- To promote rehabilitation neuroscience research that expands current neuromodulatory methods
- To increase understanding of the neurobiological mechanisms underlying such neuromodulatory treatment The specific aims / hypotheses in the current study are:
- Aim 1: Demonstrate the safety, feasibility and tolerability of high-dose, accelerated, network targeted rTMS in the basal ganglia-cerebellar-motor network. Working hypothesis: The approach will be safe, feasible and well tolerated by the patients.
- Aim 2: Demonstrate preliminary efficacy of high-dose, accelerated, network-targeted rTMS on freezing of gait. Working hypothesis: The approach facilitates recovery in motor network dysconnectivity, and thereby will improve FOG after treatment compared to pre-treatment.
- Aim 3: Demonstrate modulation of functional connectivity aftereffects of high-dose, accelerated, network-targeted rTMS. Working hypothesis: Functional connectivity as assessed with fMRI will change after the high-dose, accelerated, functionally-guided stimulation treatment compared to pre-treatment.
- Conditions
- Parkinson Disease
- Being tested
- rTMS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called MagPro X100 magnetic stimulator with a 90mm figure-8 coil (MC-B70, MagVenture Inc.)
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to six treatment days
Retention rate
Percentage of participants enrolled who completed the study.
Measured: 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.
Measured: 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
Measured: 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
Squared distance (error) from the cursor to the target in precision force-tracking task, estimated as the root mean squared error (RMSE).
Measured: 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
Basal ganglia-cerebellar-cortical network defined by BOLD change while subject performs the precision force-tracking task *Optional
Measured: Baseline; 7-10 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2027 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vesia, PhD, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509842
- Sponsor's protocol ID
- HUM00212090
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Accelerated Theta Burst Stimulation to Restore PD-induced Motor Network Dysconnectivity
- ClinicalTrials.gov ID
- NCT05509842
- Acronym / sponsor ID
- HUM00212090
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- The proposed research will characterize how inter-individual brain and behavior differences (i.e., gait function behavior and fMRI functional connectivity) at baseline relate to the treatment response.
- This knowledge will provide important information about how interventions can be personalized and optimized.
- The work may increase understanding of the underlying neurobiological mechanisms of neuromodulation for rehabilitation in patients with gait disturbances due to PD.
- Impact: Results will provide insights into the effects of the neuromodulatory treatment on gait and motor dysfunction and could dramatically improve quality of life for patients with PD. The results also will (1) provide a mechanistic foundation for studies of therapeutic iTBS for PD patients, (2) evaluate novel stimulation targets, and (3) markedly condense the duration of treatment into a more manageable timeframe for patients.
Our overall objectives in the current study are to:
- To establish safety, feasibility, and tolerability of a high-dose, resting-state functional connectivity-guided iTBS
- To elucidate the neural mechanism by which such a highly efficient and personalized stimulation approach leads to improvements in freezing of gait in PD.
- To promote rehabilitation neuroscience research that expands current neuromodulatory methods
- To increase understanding of the neurobiological mechanisms underlying such neuromodulatory treatment The specific aims / hypotheses in the current study are:
- Aim 1: Demonstrate the safety, feasibility and tolerability of high-dose, accelerated, network targeted rTMS in the basal ganglia-cerebellar-motor network. Working hypothesis: The approach will be safe, feasible and well tolerated by the patients.
- Aim 2: Demonstrate preliminary efficacy of high-dose, accelerated, network-targeted rTMS on freezing of gait. Working hypothesis: The approach facilitates recovery in motor network dysconnectivity, and thereby will improve FOG after treatment compared to pre-treatment.
- Aim 3: Demonstrate modulation of functional connectivity aftereffects of high-dose, accelerated, network-targeted rTMS. Working hypothesis: Functional connectivity as assessed with fMRI will change after the high-dose, accelerated, functionally-guided stimulation treatment compared to pre-treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open label treatment | Experimental | Device: rTMSAll 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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSAlso: MagPro X100 magnetic stimulator with a 90mm figure-8 coil (MC-B70, MagVenture Inc.)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). | Device | Open label treatment |
Primary outcome
Participant perception of treatment acceptability
Time frame: up to six treatment days
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.
Retention rate
Time frame: Change from Baseline prior to treatment and at follow-up within 1 week post-treatment
Percentage of participants enrolled who completed the study.
Percentage change in TUG test time to 48 hours and 14 days post-intervention
Time frame: Change from Baseline; 48 hours post; 14 days post -intervention
Time to complete the full TUG protocol.
Net changes in FOG-Q scores at 48 hours and 14 days post-intervention
Time frame: Change from Baseline; 48 hours post; 14 days post -intervention
Net changes in FOG-Q scores at 48 hours and 14 days post-intervention
2 secondary outcomes
Percentage change in accuracy to precision force-tracking task at 48 hours and 14 days post-intervention
Time frame: 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
Time frame: Baseline; 7-10 hours post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Rettmann (734-763-2790, arettman@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant perception of treatment acceptability (time frame: up to six treatment days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.