Treatment for Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
Stanford Neuroscience Health Center, Palo Alto, CA
Stroke+5 More
Eligibility
18+
All Sexes
Eligible conditions
Stroke

Study Summary

This study is evaluating whether a vibrating device can improve the range of movement and spasticity in the hand of people with stroke.

See full description

Eligible Conditions

  • Stroke
  • Spastic
  • Wake-up Stroke
  • Hemorrhagic Stroke
  • Stroke, Ischemic
  • Spasticity as Sequela of Stroke
  • Muscle Spasticity
  • Ischemic Stroke

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 4 primary outcomes in patients with Stroke. Measurement will happen over the course of Change from Baseline Modified Ashworth at 12 weeks.

Week 12
Change in Modified Ashworth at 12 weeks
Week 8
Change in Modified Ashworth at 8 weeks
Week 12
Change in Range of Motion at 12 weeks
Week 8
Change in Range of Motion at 8 weeks

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

11 Treatment Groups

Vibration pattern 8
Placebo group

This trial requires 70 total participants across 11 different treatment groups

This trial involves 11 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Vibration pattern 8
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 1
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 9
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 2
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 3
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 7
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 4
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 5
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Vibration pattern 6
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
No vibration
Device
A light will blink instead of a vibration pattern being displayed.
Vibration pattern 10
Device
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline range of motion at 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline range of motion at 8 weeks for reporting.

Who is running the study

Principal Investigator
A. O.
Prof. Allison Okamura, Professor
Stanford University

Closest Location

Stanford Neuroscience Health Center - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
able to provide informed consent.
Age 18 and older.
diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.

Patient Q&A Section

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

What causes stroke?

Add answer

In a recent study, findings suggest that a higher level of circulating oxidized LDL (lipid A from oxidized LDL) is the major cause of acute ischemic stroke in mice and that lipid A activates tissue factor. Furthermore, lipid A may play an important role in the pathogenesis of acute ischemic stroke.

Unverified Answer

Can stroke be cured?

Add answer

Approximately 40% of all strokes are due to an identifiable cause (45% due to atherosclerosis), and in those with large arterial occlusions (>or=70%), the mortality and disability rates are very low. Therefore, it is reasonable to focus stroke prevention efforts in this group of patients. However, strokes that occur in the first hour after the onset of a stroke symptoms may still not be able to be prevented if there are no other, identifiable risk factors, or if there are other reasons to treat them.

Unverified Answer

What are common treatments for stroke?

Add answer

Among participants with incident stroke, about 20% had a single event, 9% had a recurrent event, and 2 to 3% died during the first year of follow-up.

Unverified Answer

What are the signs of stroke?

Add answer

Signs of stroke of the brain can include mild/moderate/severe confusion or a lack of sensation, or vision problems including loss of eye movement. A sensation of numbness is often transient and may not be indicative of a serious complication. Aphasia is a sign of a recent stroke and may occur during the acute phase. Other signs include difficulty moving or feeling (paresis), loss of coordination (ataxia), speech problems or difficulty speaking (dysphasia) and decreased intelligence. Seizures can occur in people with epilepsy. Other signs may include a headache or a neck ache and can be indicative of cerebral palsy.

Unverified Answer

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

Add answer

For every 1000 people with diabetes, there are 4 people with a first stroke per year. For every 1000 people with hypertension, there are 35 people with a stroke per year.

Unverified Answer

What is stroke?

Add answer

Stroke remains one of the leading causes of disability in young adults. Approximately 4-6 strokes occur per 1,000 people aged 25 to 35 years. The majority of stroke is ischaemic but a significant number of ischaemic strokes are due to embolic mechanisms.

Unverified Answer

What is the average age someone gets stroke?

Add answer

The mean age of getting a stroke in the country under study is 75 years (range 57 to 91 years) This figure does not seem to differ according to sex, gender or nationality. There may be regional variations in ages and ages of getting a stroke, which could be linked to different risk factors.

Unverified Answer

Does treatment improve quality of life for those with stroke?

Add answer

While there is strong evidence that some people benefit from therapy for depression and anxiety, we did not see any evidence of improvements in functioning following stroke treatment in this study. We did  find tentative evidence of a benefit of treatment for depressive symptoms in the quality of life domain but that further research is needed.

Unverified Answer

How serious can stroke be?

Add answer

The mortality rate was high in our study, and the time interval between stroke onset and hospital admission was surprisingly long (median: 27.3 hours) and exceeded the time required for complete treatment (median: 14.6 hours). The prognosis was related to the severity of stroke as indicated by the NIHSS, though death from ischemic stroke may occur after a short interval.

Unverified Answer

What is the primary cause of stroke?

Add answer

Stroke can be more common than previously predicted in the elderly. In a recent study, findings also suggest that the risk of stroke is increased in persons receiving antihypertensive treatment with drugs.

Unverified Answer

What does treatment usually treat?

Add answer

This retrospective pilot study shows that many patients treated for an acute stroke in New Brunswick, Canada do not have a history of tobacco smoking. More research is needed to identify and treat other causal factors for stroke that have high prevalence in our community, including obesity, lipid disorders, diabetes, and hypertension.

Unverified Answer

Who should consider clinical trials for stroke?

Add answer

Trialists (either as investigator or as principal investigator) should be more comfortable in conducting clinical trials in stroke. All participants also need to be aware that they can benefit from a clinical trial, but their chances of a positive result are greater if they choose to participate.

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.