TMS for Stroke Recovery

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Texas at Austin

Must not be taking: Anti-epilepsy

Disqualifiers: Neurological disease, Seizure, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how transcranial magnetic stimulation (TMS), a non-invasive procedure using magnetic fields, can improve hand movement in people who have had a stroke. Researchers seek to determine if TMS can strengthen specific brain pathways to aid recovery. The trial targets individuals who experienced a stroke more than six months ago and continue to struggle with hand movements. Participants should not have other neurological issues or certain implants, such as pacemakers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that any recent changes to medication use within the last month may affect eligibility. It's best to discuss your specific medications with the trial team.

What prior data suggests that this TMS technique is safe for stroke recovery?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe. Studies have found that TMS can stimulate brain activity without major issues. Most people experience only mild side effects, such as headaches or scalp discomfort, which typically resolve on their own.

Research on TMS for stroke recovery suggests it can improve movement without causing serious problems. Another study confirmed that TMS is safe for both research and medical use.

Overall, while no treatment is completely risk-free, TMS has a strong safety record, especially when performed by professionals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Transcranial Magnetic Stimulation (TMS) is unique for stroke recovery because it uses magnetic fields to stimulate nerve cells in the brain. Unlike traditional rehabilitation methods like physical and occupational therapy, which focus on retraining the body and brain, TMS directly targets brain activity to promote neural regeneration and connectivity. Researchers are excited about TMS because it offers a non-invasive approach that could potentially speed up recovery times and improve outcomes by directly enhancing brain function.

What evidence suggests that TMS is effective for stroke recovery?

Research has shown that transcranial magnetic stimulation (TMS) can improve movement after a stroke. Studies have found that repetitive TMS enhances the use of affected limbs by strengthening the brain's control over muscles. Some studies also suggest it might aid other brain functions impacted by a stroke. In short, TMS shows promise in helping stroke survivors recover by improving movement and cognitive abilities. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who still have some connection between their brain and hand muscles, as shown by muscle twitches in response to TMS. They must be able to give informed consent, which may involve passing tests if they have speech difficulties due to the stroke.

Inclusion Criteria

Ability to provide informed consent

Discernable and reliable motor-evoked potential (MEP) following single-pulse transcranial magnetic stimulation to the lesioned hemisphere

I have weakness in one of my arms.

Exclusion Criteria

My arm movement score is 66.

Mini Mental State Exam score <= 24

I have a history of neurological conditions, but not stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Initial Testing

Participants undergo initial testing including informed consent, eligibility screening, and clinical assessment of motor impairment

1 day

1 visit (in-person)

TMS Intervention

Participants receive TMS intervention to identify brain activity patterns and determine TMS intensity for muscle twitch elicitation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation (TMS)

Trial Overview The study is testing a personalized approach using Transcranial Magnetic Stimulation (TMS) on post-stroke patients. It aims to find specific brain activity patterns that make TMS more effective at activating residual connections in the brain that control hand movement.

Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraine Headache Symptoms

Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

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+

Published Research Related to This Trial

In a study involving 12 patients with chronic stroke, high-frequency repetitive transcranial magnetic stimulation (rTMS) was found to be safe, with no new symptoms reported and only a modest increase in systolic blood pressure.

Patients showed modest improvements in motor function, such as grip strength and range of motion, particularly in younger individuals, suggesting potential benefits of rTMS for reducing motor deficits after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and behavioral effects of high-frequency repetitive transcranial magnetic stimulation in stroke. Yozbatiran, N., Alonso-Alonso, M., See, J., et al.[2018]

In a study involving 10 patients with chronic stroke, intermittent theta burst stimulation (TBS) of the affected motor cortex improved grip-lift performance, while sham stimulation led to a decline in function.

Continuous TBS of the unaffected motor cortex resulted in decreased upper-limb function, suggesting that the contralesional hemisphere may hinder recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining theta burst stimulation with training after subcortical stroke. Ackerley, SJ., Stinear, CM., Barber, PA., et al.[2022]

In a study of 165 pediatric participants aged 6 to 18, theta-burst TMS (TBS) demonstrated a similar safety profile to single- and paired-pulse TMS (sp/ppTMS), with no severe adverse effects reported.

The overall rate of adverse effects was 10.5% for TBS and 12.4% for sp/ppTMS, with most effects rated as minimal or mild, indicating that TBS is a safe option for further investigation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. Hong, YH., Wu, SW., Pedapati, EV., et al.[2020]

Theta burst stimulation (TBS) is a promising technique for altering brain excitability, with a review of studies showing that adverse events were mostly mild and occurred in only 5% of subjects, indicating a generally safe profile.

Despite its safety, TBS carries a theoretical higher risk of seizures compared to other stimulation methods, necessitating cautious application and further research into its dosing parameters to better understand seizure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. Oberman, L., Edwards, D., Eldaief, M., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) shows variable effects on corticospinal pathway excitability in healthy adults, with different frequencies producing different outcomes, indicating that the optimal parameters for rTMS are not yet established.

In stroke patients, there is a trend suggesting that 10 sessions of 3 Hz rTMS may aid in the recovery of motor-evoked potentials, but overall evidence is insufficient to determine effective dosing for improving motor function in paretic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing dose-finding studies of repetitive transcranial magnetic stimulation to enhance motor function: a qualitative systematic review. Hiscock, A., Miller, S., Rothwell, J., et al.[2018]

In a study involving 20 chronic ischemic stroke patients, both continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) combined with physical therapy showed significant improvements in motor function and daily living activities after 10 treatment sessions.

While both real cTBS and rTMS were effective, only rTMS significantly reduced spasticity in multiple muscle groups, indicating that while these interventions help with functional recovery, their impact on spasticity may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Sham Controlled Continuous Theta Burst Stimulation and Low Frequency Repetitive Transcranial Magnetic Stimulation on Upper Extremity Spasticity and Functional Recovery in Chronic Ischemic Stroke Patients. Kuzu, Ö., Adiguzel, E., Kesikburun, S., et al.[2021]

In a study involving 10 stroke patients, combining Theta Burst Stimulation (TBS) with Neuromuscular Electrical Stimulation (NMES) resulted in significantly greater improvements in motor-cortex integrity and reaction time compared to either treatment alone.

The combined approach not only enhanced cortical excitability but also improved functional performance as measured by the 9 Hole Peg Test, suggesting that this synergistic method may be more effective for rehabilitation after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of central plus peripheral stimulation (CPPS) on post stroke upper limb motor rehabilitation. Khan, FR., Chevidikunnan, MF.[2018]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Prolonged continuous theta burst stimulation (cTBS) applied to carotid stents in a study with isolated swine arteries showed no significant changes in stent morphology or thermal damage, indicating its safety for use in patients with vascular stents.

The study found no visible migration of the stents or significant temperature elevation during cTBS, suggesting that this method can be safely used for neuro-rehabilitation in stroke patients with stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of carotid artery stent in repetitive transcranial magnetic stimulation-The histopathological proof from swine carotid artery. Fong, PY., Chuang, WY., Huang, YZ., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) significantly improves upper limb motor function in stroke patients, with a moderate effect size (SMD 0.43) based on a meta-analysis of nine studies involving 289 patients.

Low frequency rTMS appears to be particularly effective for motor recovery in stroke patients, and the treatment is relatively safe, with only three reported adverse effects among the studies analyzed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of repetitive transcranial magnetic stimulation on upper limb motor function in patients with stroke: a meta analysis]. Ling, HM., Tao, T., Xu, J., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) have been shown to effectively modulate cortical excitability in stroke patients, with low frequency rTMS decreasing resting motor thresholds and increasing motor-evoked potentials in the affected brain area.

High frequency rTMS and intermittent TBS specifically enhance cortical excitability in the affected motor area, suggesting these protocols can aid in motor recovery after a stroke, while the effects of continuous TBS remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial magnetic stimulation in modulating cortical excitability in patients with stroke: a systematic review and meta-analysis. Bai, Z., Zhang, J., Fong, KNK.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10239808/

Repetitive transcranial magnetic stimulation for stroke ... In this review, we would like to summarized the clinical benefits of rTMS for stroke rehabilitation, including improvements of motor impairment, dysphagia, ...

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043159

Evidence of rTMS for Motor or Cognitive Stroke Recovery Repetitive transcranial magnetic stimulation holds the potential to benefit a range of motor and cognitive outcomes after stroke.

3. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02714-0

Research on transcranial magnetic stimulation for stroke ... This study aimed to analyze recent research and emerging trends in transcranial magnetic stimulation (TMS) for stroke rehabilitation.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05554861

Effects of Repetitive Transcranial Magnetic Stimulation ... The aim of our study is to investigate the effects of rTMS applications at different current frequencies (low frequency / intermittent (intermittent) theta ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715924006652

Repetitive Transcranial Magnetic Stimulation for Motor ... Repetitive transcranial magnetic stimulation (rTMS) has shown promising results in enhancing motor recovery after stroke, but nuances regarding its use, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3260517/

Safety of Theta Burst Transcranial Magnetic Stimulation Transcranial Magnetic Stimulation (TMS) can be used to experimentally manipulate brain activity, and is capable of inducing long-term (on the order of minutes ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1388245720305149

Safety and recommendations for TMS use in healthy ... This is the third article on safety of use of repetitive Transcranial Magnetic Stimulation (rTMS) in clinical practice and research following by eleven years ...

8. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of major depression.

9. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1197422/full

Repetitive transcranial magnetic stimulation for stroke ... In this review, we would like to summarized the clinical benefits of rTMS for stroke rehabilitation, including improvements of motor impairment, dysphagia, ...