Magnetic Stimulation for Stroke Survivors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Antipsychotics, Antidepressants, Benzodiazepines, Stimulants

Disqualifiers: Neurological, Orthopedic, Psychiatric, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether transcranial magnetic stimulation (TMS) can improve hand function in stroke survivors. TMS uses magnetic fields to stimulate specific brain areas. Researchers will assess its effectiveness by using real-time brain activity patterns to guide the treatment, known as real-time, personalized brain state-dependent TMS. Right-handed individuals without a history of major neurological conditions or head injuries are good candidates for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance stroke recovery treatments.

Will I have to stop taking my current medications?

Yes, if you are currently using medications that affect the central nervous system, such as antipsychotics, antidepressants, benzodiazepines, or prescription stimulants, you will need to stop taking them to participate in this trial.

What prior data suggests that this method is safe for neurotypical adults?

Research has shown that real-time, personalized brain state-dependent transcranial magnetic stimulation (TMS) is safe for both healthy individuals and those recovering from a stroke. One study confirmed that this type of TMS can be administered accurately and effectively in these groups. Another study emphasized the safety of high-dose TMS specifically for stroke recovery. Experts agree that TMS is safe across different groups, including healthy individuals.

Overall, this treatment is well-tolerated, with no major side effects reported in these studies. Participants can expect a safe experience with this TMS method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about real-time, personalized brain state-dependent TMS for stroke survivors because it offers a cutting-edge approach to rehabilitation. Unlike traditional stroke therapies that often focus on physical exercises or medications, this technique uses transcranial magnetic stimulation (TMS) to directly target and stimulate specific brain areas. What makes it particularly promising is its ability to personalize treatment in real-time based on the patient's current brain state, potentially leading to more effective and faster recovery. By tailoring the stimulation to the individual's needs, it holds the promise of enhancing neural plasticity and improving outcomes compared to conventional methods.

What evidence suggests that real-time, personalized brain state-dependent TMS is effective for stroke recovery?

Research has shown that a new method of using TMS, tailored to a person's brain activity in real-time, stimulates the brain's movement control area more effectively than the standard method. Studies have found that specific brain activity patterns can predict how well this brain area activates in healthy individuals. Using these patterns to guide TMS might enhance muscle responses. Early research indicates that this approach benefits both healthy individuals and those recovering from a stroke. Although more studies are needed, these findings are promising for improving hand function after a stroke. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for neurotypical adults who can visit the lab for a day. They should be able to provide informed consent and pass eligibility screening, which includes not having certain conditions that could interfere with the study.

Inclusion Criteria

Ability to provide informed consent

Right-hand dominance

I am willing to participate in the clinical trial.

Exclusion Criteria

Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS) including: history of adverse reactions to TMS or PNS, history of stroke or head injury, metal in head, eyes, neck, chest/trunk, or arms, implanted devices, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system including antipsychotic drugs, antidepressants, benzodiazepines, prescription stimulants

I have a history of serious brain, bone, mental health, or heart conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Testing and Model Building

Participants undergo TMS testing to determine optimal stimulation parameters and build a personalized mathematical model for brain state-dependent TMS.

1 day

1 visit (in-person)

Real-time TMS Application

Real-time TMS is applied based on the personalized model to test feasibility of brain state-dependent stimulation.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects or adverse reactions post-TMS application.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Real-time, personalized brain state-dependent TMS

Trial Overview The study tests if personalized brain state-dependent Transcranial Magnetic Stimulation (TMS) can enhance muscle response by stimulating the brain during specific activity patterns. It involves recording muscle and brain activity to create a model for real-time TMS delivery.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06533176

Real-time Personalized Brain State-dependent TMS After ... This project will test whether personalized brain state-dependent TMS can activate the residual corticospinal tract better than standard TMS.

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1427198/full

Brain state-dependent repetitive transcranial magnetic ... The therapeutic potential of brain state-dependent rTMS in the rehabilitation of upper limb motor impairment post-stroke remains unexplored. Objective: Proof-of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381265/

Brain state-dependent repetitive transcranial magnetic ... The therapeutic potential of brain state-dependent rTMS in the rehabilitation of upper limb motor impairment post-stroke remains unexplored. Objective. Proof-of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24013925

Personalized whole-brain activity patterns predict human ... Our results show for the first time that personalized whole-brain EEG activity patterns predict CST activation in real-time in healthy humans.

5. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)00369-3/pdf

Developing personalized brain state-dependent TMS to target ... Results demonstrate that real-time personalized. BSD-TMS is both feasible and accurate in neurotypical adults and stroke survivors. Overall, our findings ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25000403

Efficacy and safety of high-dose and personalized TBS on ... This study highlights the efficacy and safety of high-dose iTBS targeting the individualized FCN for post-stroke cognitive recovery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines