Transcranial Magnetic Stimulation for Stroke

(CAM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by George F Wittenberg, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Serious illness, Orthopedic problems, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to use Transcranial Magnetic Stimulation (TMS) while subjects are making reaching movements in a robotic arm device in order to discover how different brain areas control movement before and after stroke and when these brain areas are most sensitive to TMS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study coordinators for more details.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for stroke recovery?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help improve motor function and reduce disability after a stroke by balancing brain activity between the two sides of the brain. Studies have found that rTMS can aid in the recovery of lower limb function and enhance overall motor recovery in stroke patients. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) generally safe for humans?

Transcranial magnetic stimulation (TMS), including repetitive TMS (rTMS), has been studied for safety in both healthy individuals and those with various conditions. While it is generally considered safe, there have been reports of seizures and other adverse effects, so guidelines have been developed to minimize risks. Safety guidelines have been updated over the years, with the most recent in 2021, to ensure safe application in clinical settings. ^{6 7 8 9 10}

How is the treatment Transcranial Magnetic Stimulation (rTMS) unique for stroke recovery?

Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain, which can help improve motor function and recovery after a stroke. Unlike traditional therapies, rTMS can target specific brain areas to restore balance between brain hemispheres, potentially leading to sustained improvements in motor skills. ^{3 6 11 12 13}

Research Team

George F Wittenberg, MD PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

This trial is for English-speaking adults aged 45-90 who've had a stroke at least 6 months ago, resulting in mild to moderate arm dysfunction. They must be medically stable and have no serious illnesses that would affect participation. People with visual loss, joint motion issues, or conditions preventing safe TMS/MRI use cannot join.

Inclusion Criteria

I am between 45 and 90 years old.

I had a stroke more than 6 months ago.

I had a stroke in a deep part of my brain.

Exclusion Criteria

Unable to comply with requirements of the study

I do not have a serious illness that would stop me from joining.

You have a medical condition or implant that makes it unsafe for you to have TMS or MRI.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcranial Magnetic Stimulation (TMS) while performing reaching movements in a robotic system

Immediate (within 2 s after stimulation)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcranial Magnetic Stimulation (Device)

Trial Overview The study uses Transcranial Magnetic Stimulation (TMS) while participants make movements with a robotic arm device to understand how the brain controls movement before and after a stroke and when it's most responsive to TMS.

Participant Groups

Group I: Reaching with TMS Experimental Treatment 1 Intervention

All participants enrolled in this group will receive TMS while performing reaching movements in a robotic system.

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

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh, PA

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1691

Patients Recruited

3,759,000+

VA Pittsburgh Healthcare System

Collaborator

Trials

36

Patients Recruited

15,900+

University of Pittsburgh

Collaborator

Trials

1820

Patients Recruited

16,360,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evidence of rTMS for Motor or Cognitive Stroke Recovery: Hype or Hope? [2023] Evidence of efficacy of repetitive transcranial magnetic stimulation (rTMS) for stroke recovery is hampered by an unexplained variability of reported effect sizes and an insufficient understanding of mechanisms of action. We aimed to (1) briefly summarize evidence of efficacy, (2) identify critical factors to explain the reported variation in effects, and (3) provide mechanism-based recommendations for future trials.

2. United States pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for the Treatment of Lower Limb Dysfunction in Patients Poststroke: A Systematic Review with Meta-Analysis. [2020] To investigate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in recovery of lower limb dysfunction in patients poststroke.

3. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation at 1Hz and 5Hz produces sustained improvement in motor function and disability after ischaemic stroke. [2022] Repetitive transcranial magnetic stimulation (rTMS) is a simple and non-invasive method of augmenting motor recovery after stroke, probably mediated by restoring inter-hemispheric activation balance. This placebo-controlled pilot study examined the possible benefit of stimulating the lesioned hemisphere (5-Hz rTMS) or inhibiting the contra-lesional hemisphere (1-Hz rTMS) on clinical recovery of motor function in patients with ischaemic stroke and assessed the sustainability of the response.

4. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of lower limb motor function in patients with stroke: a systematic review and meta-analysis of randomized controlled trials. [2022] The aim of this study was to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on the post-stroke recovery of lower limb motor function.

5. United States pubmed.ncbi.nlm.nih.gov

Informing dose-finding studies of repetitive transcranial magnetic stimulation to enhance motor function: a qualitative systematic review. [2018] Repetitive transcranial magnetic stimulation (rTMS) of the lesioned hemisphere might enhance motor recovery after stroke, but the appropriate dose (parameters of rTMS) remains uncertain. The present review collates evidence of the effect of rTMS on corticospinal pathway excitability and motor function in healthy adults and in people after stroke.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety study of high-frequency transcranial magnetic stimulation in patients with chronic stroke. [2016] Repetitive transcranial magnetic stimulation (rTMS) is a potential therapeutic tool to rehabilitate chronic stroke patients. In this study, the safety of high-frequency rTMS in stroke was investigated (Phase I).

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023] Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.

8. Ireland pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022] Single-pulse transcranial magnetic stimulation (TMS) is a safe and useful tool for investigating various aspects of human neurophysiology, particularly corticospinal function, in health and disease. Repetitive TMS (rTMS), however, is a more powerful and potentially dangerous modality, capable of regionally blocking or facilitating cortical processes. Although there is evidence that rTMS is useful for treating clinical depression, and possibly other brain disorders, it had caused 7 known seizures by 1996 and could have other undesirable effects. In June 1996 a workshop was organized to review the available data on the safety of rTMS and to develop guidelines for its safe use. This article summarizes the workshop's deliberations. In addition to issues of risk and safety, it also addresses the principles and applications of rTMS, nomenclature, and potential therapeutic effects of rTMS. The guidelines for the use of rTMS, which are summarized in an appendix, cover the ethical issues, recommended limits on stimulation parameters, monitoring of subjects (both physiologically and neuropsychologically), expertise and function of the rTMS team, medical and psychosocial management of induced seizures, and contra-indications to rTMS.

9. United States pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. [2005] The side effects of repetitive transcranial magnetic stimulation are largely unexplored and the limits of safe exposure have not been determined except as regards the acute production of seizures. Although tissue damage is unlikely, however, cognitive and other adverse effects have been observed and the possibility of unintended long-term changes in brain function are theoretically possible.

10. Netherlands pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. [2021] Transcranial magnetic stimulation (TMS) can cause seizures in healthy individuals and patients. However, the rate at which this occurs is unknown. We estimated the risk of seizure and other adverse events with TMS.

11. Iran pubmed.ncbi.nlm.nih.gov

The Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Functional Indices of Affected Upper Limb in Patients with Subacute Stroke. [2022] Repetitive transcranial magnetic stimulation (rTMS) is a novel technique that may improve recovery in patients with stoke, but the role of rTMS as an applied and practical treatment modality for stroke rehabilitation has not been established yet.

12. Malaysia pubmed.ncbi.nlm.nih.gov

Cortical Modulation After Two Different Repetitive Transcranial Magnetic Stimulation Protocols in Similar Ischemic Stroke Patients. [2022] Stroke is one of the leading causes of mortality and morbidity in Malaysia. Repetitive transcranial magnetic stimulation (rTMS) is one of the new non-invasive modality to enhance the motor recovery in stroke patients.

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation combined with functional electrical stimulation on hand function of stroke: A randomized controlled trial. [2022] Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been widely used for hand function recovery in patients with subacute and chronic stroke.