Neural Stimulation for Stroke

EP
PC
Overseen ByPeter C Gerszten, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how the nervous system changes after a stroke by testing how neck nerves respond to electrical stimulation. It focuses on individuals who have experienced a stroke and suffer from one-sided weakness. Participants will undergo spinal surgery where a Bipolar Neural Stimulation Electrode stimulates neck nerves to study their motor responses. The trial seeks individuals undergoing specific types of neck surgery who had a stroke more than six months ago and still experience weakness. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new insights and treatments for stroke recovery.

Will I have to stop taking my current medications?

If you are taking anti-spasticity or anti-epileptic medications, you will need to stop them to participate in this trial.

What prior data suggests that this bipolar neural stimulation electrode is safe for cervical spinal nerve root stimulation?

Research has shown that treatments using electrical stimulation, such as the Bipolar Neural Stimulation Electrode, are generally safe. For instance, studies on spinal cord stimulation, which uses similar technology, found that patients usually tolerate it well. Side effects are rare and typically minor, such as temporary discomfort.

Additionally, spinal cord and nerve root stimulation have been studied for other uses, like pain management, and have been found to be safe. This suggests that using the Bipolar Neural Stimulation Electrode for nerve root stimulation in stroke patients could also be safe, although individual experiences may differ. Discussing any concerns with healthcare professionals before joining a trial is always advisable.12345

Why are researchers excited about this trial?

Unlike the standard stroke treatments, which typically focus on medication and rehabilitation therapies, the Bipolar Neural Stimulation Electrode uses electrical stimulation to directly target the cervical dorsal spinal nerve roots. This innovative approach aims to enhance neural recovery by activating specific nerve pathways, something current options don't directly address. Researchers are excited because this method could potentially speed up recovery times and improve outcomes by directly influencing the nervous system's response to a stroke.

What evidence suggests that this neural stimulation technique is effective for stroke?

Research shows that electrical stimulation methods, such as the Bipolar Neural Stimulation Electrode, may aid stroke recovery. In this trial, participants will receive direct electrical stimulation to the cervical dorsal spinal nerve roots. A review of studies has found that electrical stimulation improves recovery in stroke patients. Another study found that spinal cord stimulation helped improve movement in people with neurological issues. Additionally, evidence suggests that stimulating peripheral nerves can reduce pain and support physical recovery. These findings indicate that neural stimulation might aid stroke recovery by improving movement and reducing symptoms.46789

Who Is on the Research Team?

PC

Peter C Gerszten, MD

Principal Investigator

University of Pittsburgh, Neurological Surgery

Are You a Good Fit for This Trial?

This trial is for people aged 21-75 with conditions like stroke, brain injury, or other nervous system disorders. It includes those undergoing cervical spinal surgery and electrophysiological monitoring. Stroke survivors must be more than 6 months post-event with resulting hemiparesis.

Inclusion Criteria

I am having elective neck spine surgery with nerve monitoring.
I had a stroke over 6 months ago and have weakness on one side, and I'm getting a specific neck surgery.
I am between 21 and 75 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive direct electrical stimulation to the cervical dorsal spinal nerve roots during surgery

1 day
1 visit (in-person, intra-operative)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bipolar Neural Stimulation Electrode

Trial Overview

The study tests how stimulating neck nerve roots affects motor responses in patients with neurological disorders. This involves using a bipolar neural stimulation electrode during surgery to understand changes in spinal sensory pathways.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dorsal Spinal Nerve Root StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Peter C. Gerszten, MD

Lead Sponsor

Citations

A systematic review on functional electrical stimulation based ...

The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery ...

SPINAL CORD STIMULATION IMPROVES MOTOR ...

Here, we report the final outcomes of a pilot clinical trial testing preliminary efficacy and safety of cervical epidural spinal cord ...

Brain Electrical Stimulation to Enhance Recovery After Stroke

This study will examine whether brain stimulation using transcranial direct current stimulation (tDCS) in stroke patients undergoing rehabilitation therapy ...

The effects of stimulation waveform and carrier frequency ...

First study examining transcutaneous spinal cord stimulation (tSCS) carrier frequencies and waveforms in stroke survivors.

Retrospective Evaluation of Bipolar Peripheral Nerve ...

Preclinical and clinical data have shown reduction in pain and improvement in physiological recovery with peripheral nerve stimulation. Unlike ...

Stimulation-Based Modulation of Spinal and Cortical ...

This data is critical to reveal changes to the spinal sensory modulating circuitry in neurological disorders like stroke. Detailed Description.

Neural Stimulation for Stroke · Info for Participants

The study tests how stimulating neck nerve roots affects motor responses in patients with neurological disorders. This involves using a bipolar ...

Non-invasive electrical and magnetic stimulation of the brain ...

This up-dated review covers theoretical, physiological and practical aspects of non-invasive stimulation of brain, spinal cord, nerve roots and peripheral ...

Spinal cord and deep brain stimulation for neuropathic pain

Spinal cord stimulation: a real-world data analysis on outcomes and differences between rechargeable and non-rechargeable implantable pulse ...