Phase-dependent paired corticomotoneuronal stimulation (PCMS) for Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Texas at Austin, Austin, TX
Stroke
Phase-dependent paired corticomotoneuronal stimulation (PCMS) - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Stroke

Study Summary

This study is evaluating whether combined brain and nerve stimulation can improve hand function after stroke.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Phase-dependent paired corticomotoneuronal stimulation (PCMS) will improve 2 primary outcomes and 2 secondary outcomes in patients with Stroke. Measurement will happen over the course of up to 1 hour after intervention.

Hour 1
Amplitude of motor evoked potentials
Maximum hand force output
Maximum hand muscle activation
Time to complete the 9-hole peg test

Trial Safety

Trial Design

4 Treatment Groups

PCMS during random brain states
PCMS during brain states reflecting strong corticospinal transmission

This trial requires 45 total participants across 4 different treatment groups

This trial involves 4 different treatments. Phase-dependent Paired Corticomotoneuronal Stimulation (PCMS) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

PCMS during brain states reflecting strong corticospinal transmission
CombinationProduct
Paired corticomotoneuronal stimulation during sensorimotor mu rhythm trough phases
CombinationProduct
PCMS during random brain states
CombinationProduct
Paired corticomotoneuronal stimulation during random sensorimotor mu rhythm phases
CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 hour after intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 hour after intervention for reporting.

Closest Location

University of Texas at Austin - Austin, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
History of stroke > 6 months ago
Presence of residual upper extremity hemiparesis
Willingness to participate
You are able to provide informed consent. show original
Upper extremity Fugl-Meyer score < 66
You have a mini mental state examination score of at least 24. show original
Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can stroke be cured?

Add answer

Stable ischemic lesions usually do not result in an improvement. Furthermore, after successful fibrinolysis in ischemic-like emboli, the rate of recurrent strokes is not higher than in asymptomatic patients after a matched follow-up period. Therefore, the view persists to consider the embolic mechanism in acute stroke.

Unverified Answer

What causes stroke?

Add answer

Atherosclerosis, hypertension and diabetes are major causes of stroke. Some strokes such as subarachnoid hemorrhage occur when there is no atherosclerotic plaques in the blood vessels of the brain. This process is known as a'small arterial dissection'. Other strokes such as ischaemic strokes occur when there is a disruption in blood flow through normal arteries in the brain. Ischaemic stroke is sometimes triggered by major depressive disorders. Other less common causes of stroke include aortic aneurysm, carotid arteries or other cerebral aneurysms, intracerebral haemorrhage (during a migraine) and acute systemic inflammatory diseases. Stroke is more common in older people.

Unverified Answer

How many people get stroke a year in the United States?

Add answer

If the national hospital discharge and clinical database are to be believed, there is a considerable variation in the absolute and relative frequency of stroke among populations in each state in the United States. This suggests that stroke is not a uniformly distributed condition, although stroke incidence rate may vary among populations because of age-related factors not readily amenable to modification.

Unverified Answer

What is stroke?

Add answer

Stroke is the cause of serious injury and death of about 4.2 million people from around the world each year. It is the most common cause of motor incoordination and a major cause of hemiparesis. It kills a half of those affected each year. Patients with stroke may go on to have a second stroke in 12-13 per cent of cases (first stroke), or die later in one in three cases (first and recurrent). Approximately two thirds of patients living with disability in the United Kingdom have a stroke and nearly 80% of patients would be unable to walk without aid. Patients with stroke have poorer control of bladder and bowel functioning, are more likely to incur long-term side effects and have a worse quality of life.

Unverified Answer

What are the signs of stroke?

Add answer

People who have had a stroke will have a limited joint range of motion and altered sensation and will also be at risk of a transient ischemic attack.

Unverified Answer

What are common treatments for stroke?

Add answer

Although stroke survivors have a high prevalence of comorbidities, only 13% of patients received guideline-recommended medications after their cerebral infarction. Most received aspirin. Patients who underwent coronary artery bypass surgery were less likely to receive anticoagulants than the general stroke population.

Unverified Answer

Does stroke run in families?

Add answer

Families with stroke have a higher incidence of stroke than the general population. The increased number of strokes in the family members is, however, not associated with early stroke onset. Furthermore, early stroke onset increases with the number of strokes in the family.

Unverified Answer

What is the average age someone gets stroke?

Add answer

For adults the age of onset is typically between ages of 55 to 66, but can be as young as 43. Females are twice as likely as males to get a stroke at age 40, and people with high blood pressure are twice as likely to have a stroke at age 74. Stroke is more common in colder and wetter summers; more common in warmer and drier summers. People who smoke are 60 times more likely to sustain a stroke.

Unverified Answer

What are the latest developments in phase-dependent paired corticomotoneuronal stimulation (pcms) for therapeutic use?

Add answer

The present review describes a novel method for the stimulation of motor units in the paretic quadrant at different excitability levels, as well as the clinical relevance of these findings. Results from a recent clinical trial show a significant enhancement of motor function as well as an increase in the number of active motor units in the paretic quadrant through the use of PCMS. Results from a recent clinical trial is expected to enhance our understanding of the mechanisms governing the improvement of recovery of motor function following stroke and provide a platform for further therapeutic investigations.

Unverified Answer

What are the common side effects of phase-dependent paired corticomotoneuronal stimulation (pcms)?

Add answer

The common side effects of pcms include headache, [migraine](https://www.withpower.com/clinical-trials/migraine), nausea, vomiting, sweating, heart rate, blood pressure, and skin rash. For a long periods of time, these side effects are limited and can be managed adequately.

Unverified Answer

What is phase-dependent paired corticomotoneuronal stimulation (pcms)?

Add answer

Paired cortical stimulation results in long-term potentiation (LTP). Paired cortical stimulation results in synchronisation of the motor cortex and the lower motor neuron, and facilitates motor learning.

Unverified Answer

Have there been any new discoveries for treating stroke?

Add answer

There have been only a few new developments in treating stroke but they have had a lot of focus on developing a drug with the capability to deliver the same or better results without triggering as many adverse events as the currently used drugs do. More research needs to be done in order to discover these kinds of drugs. In the immediate future however, research on natural plant products or other natural products may have the best possibility of becoming available in the medium-to-long-term future for treatment of stroke.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Stroke by sharing your contact details with the study coordinator.