Brain State-Dependent PCMS for Stroke Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help people regain hand function after a stroke. It combines brain and nerve stimulation, known as Brain State-dependent Paired Corticomotoneuronal Stimulation (PCMS), to strengthen pathways controlling hand movements. The study will determine if timing the stimulation during specific brain states enhances recovery more than random stimulation. Individuals who had a stroke over six months ago and still struggle with hand use might be suitable candidates. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to pioneering stroke recovery advancements.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that act on the central nervous system, except for selective serotonin reuptake inhibitors (SSRIs), at least 3 months before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Brain State-dependent PCMS, a method combining brain and nerve stimulation, is generally well-tolerated. Some studies have demonstrated positive effects on movement abilities after strokes. For example, one study found that this technique improved movement and reduced difficulties in moving. Another study noted an increase in how well the brain communicates with muscles after treatment.
While these studies provide encouraging results, they are not very large. However, they suggest that the treatment does not cause major unwanted effects. As this trial is in its early stages, researchers are still collecting more data on safety. The findings so far are promising and suggest the treatment is safe for further testing.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Brain State-Dependent Paired Corticomotoneuronal Stimulation (PCMS) for stroke recovery because it takes a novel approach by synchronizing stimulation with specific brain activity patterns. Unlike traditional rehabilitation methods, which often involve physical therapy and medication, this technique aims to enhance the brain's natural ability to rewire itself by targeting optimal moments of corticospinal transmission. This precision could potentially lead to faster and more effective recovery of motor functions in stroke patients. Additionally, the trial investigates the impact of delivering PCMS during random brain states as an active comparator, offering insights into how timing can influence treatment outcomes.
What evidence suggests that this trial's treatments could be effective for stroke recovery?
This trial will compare two approaches to brain stimulation for stroke recovery. One group of participants will receive Brain State-dependent Paired Corticomotoneuronal Stimulation (PCMS) during brain states reflecting strong corticospinal transmission. Another group will receive PCMS during random brain states. Research has shown that this special type of brain stimulation can aid stroke patients in better recovery. In one study, patients who received this treatment improved their hand movement more than those who did not. This method activates the brain and nerves together to strengthen the pathways that control movement, similar to how highways carry traffic. By timing the stimulation to match certain brain activities, these pathways become stronger. Early results are promising for helping stroke patients improve their hand function by making these pathways work more efficiently.26789
Are You a Good Fit for This Trial?
This trial is for individuals who have had a stroke at least 6 months ago and now struggle with hand function due to upper extremity hemiparesis. They must be mentally fit (with a Mini Mental State Exam score over 24), willing to participate, able to consent, and have some movement in their affected arm but not full recovery (Fugl-Meyer score under 66).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combined brain and nerve stimulation during specific time windows to enhance hand function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brain State-dependent Paired Corticomotoneuronal Stimulation (PCMS)
- Phase-dependent Paired Corticomotoneuronal Stimulation (PCMS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas at Austin
Lead Sponsor