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.
What safety data exists for Transcranial Magnetic Stimulation (TMS) in stroke treatment?Safety data for Transcranial Magnetic Stimulation (TMS), including repetitive TMS (rTMS), indicates that while it is a promising therapeutic tool for stroke rehabilitation, there are safety considerations. High-frequency rTMS has been studied for safety in chronic stroke patients. Safety guidelines have been developed since 1996, with updates in 2008 and 2021, focusing on adverse events, precautions, dosing, and specific considerations for stroke. Known risks include seizures and cognitive effects, though tissue damage is unlikely. The rate of seizures is not well-defined, but guidelines exist to manage risks and ensure safe application.123812
Is Transcranial Magnetic Stimulation a promising treatment for stroke recovery?Yes, Transcranial Magnetic Stimulation (rTMS) is a promising treatment for stroke recovery. It is a non-invasive method that can help improve motor function and hand function in stroke patients. Studies show it can enhance recovery by stimulating the brain and improving movement abilities.3571011
Do I need to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Transcranial Magnetic Stimulation for Stroke is an effective treatment?The available research shows that Transcranial Magnetic Stimulation (TMS) can help improve motor function in people who have had a stroke. One study found that using TMS at different frequencies led to sustained improvements in motor skills and reduced disability after a stroke. Another study focused on lower limb recovery and found that TMS was effective in helping patients regain movement in their legs. These findings suggest that TMS can be a useful treatment for stroke recovery, especially for improving movement and reducing disability.456913
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 in a deep part of my brain.
I had a stroke that affects one side of my body and other causes have been ruled out.
Exclusion Criteria
I am unable to understand and agree to the study's procedures and risks.
I do not have joint or bone problems that limit my movement for study activities.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Reaching with TMSExperimental Treatment1 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 nearbySelect from list below to view details:
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, PA
Loading ...
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
VA Pittsburgh Healthcare SystemCollaborator
University of PittsburghCollaborator
References
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.