Non-Invasive Brain Stimulation for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Magnetic Tides

Disqualifiers: Cognitive impairment, Pregnancy, Severe cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 months

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment kTMP for stroke?

Research shows that non-invasive brain stimulation, similar to kTMP, can help improve motor function and daily activities in stroke patients. It is also being explored as a way to enhance recovery by affecting brain activity and aiding rehabilitation. ^{1 2 3 4 5}

Is non-invasive brain stimulation safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been used safely in both healthy people and those with brain-related conditions since the 1990s, with established safety guidelines. Most side effects are mild, but there is a small risk of seizures, especially with newer protocols like theta burst stimulation (TBS), so caution is advised. ^{6 7 8 9 10}

How is the treatment kTMP different from other stroke treatments?

The treatment kTMP is a form of non-invasive brain stimulation, which is unique because it aims to enhance brain recovery after a stroke by modulating brain activity without surgery or medication. Unlike traditional therapies, it uses techniques like transcranial magnetic stimulation to adjust brain excitability, potentially improving motor function by restoring balance between brain hemispheres. ^{1 3 11 12 13}

Eligibility Criteria

This trial is for individuals who have had a stroke and are living with chronic motor function impairments. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

I am 18 or older and have had stable arm problems due to a stroke over 6 months ago.

My arm and hand movement score is between 28 and 60.

Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function

Exclusion Criteria

Contraindications related to non-invasive brain stimulation

Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression

I do not have cognitive or language issues that affect my understanding or decision-making.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive kTMP or sham stimulation to assess motor function improvement

10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• kTMP

Trial Overview The trial is testing kTMP, an innovative non-invasive brain stimulation system designed to improve motor functions in people who have suffered from a stroke. Participants will be randomly assigned to receive either kTMP or a sham (fake) treatment as a comparison.

Participant Groups

Group I: Active kTMP Experimental Treatment 1 Intervention

Participants received 2-8 V/m of active stimulation

Group II: Sham kTMP Placebo Group 1 Intervention

Participants received 0.01 V/m of sham stimulation

Who Is Running the Clinical Trial?

Magnetic Tides

Lead Sponsor

Trials

2

Recruited

220+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Findings from Research

Noninvasive cortical stimulation techniques are valuable in neurorehabilitation, helping researchers understand how the brain recovers function after injury.

These techniques can modulate cortical excitability, potentially enhancing the effects of rehabilitation training and providing insights into the physiological mechanisms behind recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive cortical stimulation in neurorehabilitation: a review. Harris-Love, ML., Cohen, LG.[2016]

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]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

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]

References

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

Noninvasive cortical stimulation in neurorehabilitation: a review. [2016]

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

The Effect of Motor Cortex Stimulation on Central Poststroke Pain in a Series of 16 Patients With a Mean Follow-Up of 28 Months. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Five-day course of paired associative stimulation fails to improve motor function in stroke patients. [2022]

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

Non-invasive brain stimulation for limb motor function and daily living activity improvement in acute stroke: A meta-analysis. [2023]

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

Noninvasive brain stimulation in rehabilitation of hemispatial neglect after stroke. [2021]

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

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. [2007]

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

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]

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

Safe exposure distances for transcranial magnetic stimulation based on computer simulations. [2020]

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

A questionnaire to collect unintended effects of transcranial magnetic stimulation: A consensus based approach. [2022]

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

Primary Motor Cortex Excitability During Recovery After Stroke: Implications for Neuromodulation. [2022]

12. Romania pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation in early rehabilitation after stroke. [2018]

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

Non-invasive brain stimulation (NIBS) and motor recovery after stroke. [2022]