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Paired Associative Stimulation for Post-Stroke Recovery
N/A
Recruiting
Led By Amit Sethi, PhD
Research Sponsored by Amit Sethi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline up to 30-minutes post intervention
Awards & highlights
Study Summary
This trial looks into the effects of combining brain, nerve and hand stimulation on hand movement post-stroke, to see if it increases the connection between brain and weak muscles. It also examines changes in weak hand movement and function.
Who is the study for?
This trial is for adults aged 18-80 who've had their first subcortical stroke at least six months ago, can grasp a ball, and have the cognitive ability to participate. It's not for those with metallic head/neck implants, severe spasticity in wrist/finger muscles, other neurological disorders besides stroke, or certain psychiatric conditions.Check my eligibility
What is being tested?
The study tests how brain stimulation combined with nerve and hand stimulation affects hand movement after a stroke. Participants will receive either real or sham (fake) stimulations to see if this improves the connection between the brain and weak hand muscles as well as hand function.See study design
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from stimulation devices or skin irritation. Since it involves non-invasive techniques, serious side effects are unlikely but could involve muscle fatigue or slight headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline up to 30-minutes post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline up to 30-minutes post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Transcranial magnetic stimulation to evaluate corticospinal transmission
Secondary outcome measures
Box and Block Test
Maximum finger excursions to evaluate motor performance
Maximum finger spread to evaluate motor performance
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Task-specific sham-PCMS, Task-specific PCMS, PCMS-restExperimental Treatment3 Interventions
During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice.
During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.
During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
Group II: Task-specific sham-PCMS, PCMS-rest, Task-specific PCMSExperimental Treatment3 Interventions
During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice.
During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.
During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
Group III: Task-specific PCMS, Task-specific sham-PCMS, PCMS-restExperimental Treatment3 Interventions
During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice.
During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.
During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
Group IV: Task-specific PCMS, PCMS-rest, Task-specific sham-PCMSExperimental Treatment3 Interventions
During Task-specific paired corticospinal-motor neuronal stimulation (PCMS) participants will receive PCMS [Transcranial Magnetic Stimulation (TMS) + Peripheral Nerve Stimulation (PNS)] with task-specific practice.
During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.
During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
Group V: PCMS-rest, Task-specific sham-PCMS, Task-specific PCMSExperimental Treatment3 Interventions
During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice.
During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.
During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
Group VI: PCMS-rest, Task-specific PCMS, Task-specific sham-PCMSExperimental Treatment3 Interventions
During Task-specific PCMS participants will receive PCMS (TMS + PNS) with task-specific practice.
During PCMS rest participants will receive PCMS (TMS + PNS) without task-specific practice.
During Task-specific sham-PCMS participants will receive task-specific practice with sham PCMS (TMS + PNS).
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Who is running the clinical trial?
Amit SethiLead Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled
2 Trials studying Stroke
34 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,757 Total Patients Enrolled
79 Trials studying Stroke
5,347 Patients Enrolled for Stroke
Amit Sethi, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
14 Total Patients Enrolled
1 Trials studying Stroke
14 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I struggle to stay alert or keep still.I have a psychiatric diagnosis or am taking psychotropic medication.I can partially grasp a ball with my hand.My stroke happened more than six months ago.I have had one stroke that affected the deeper parts of my brain.I experience severe pain in my weak hand, scoring over 4 on a pain scale.I have a history of seizures or epilepsy.I have a neurological disorder that is not a stroke.My tests show I can't move a specific muscle even with effort.My wrist and finger muscles are very stiff.I have arthritis or similar conditions affecting my arms or hands.I am between 18 and 85 years old.I have severe difficulty speaking or understanding speech.My mental ability to participate is confirmed by a specific test score.
Research Study Groups:
This trial has the following groups:- Group 1: Task-specific PCMS, PCMS-rest, Task-specific sham-PCMS
- Group 2: Task-specific PCMS, Task-specific sham-PCMS, PCMS-rest
- Group 3: PCMS-rest, Task-specific PCMS, Task-specific sham-PCMS
- Group 4: PCMS-rest, Task-specific sham-PCMS, Task-specific PCMS
- Group 5: Task-specific sham-PCMS, Task-specific PCMS, PCMS-rest
- Group 6: Task-specific sham-PCMS, PCMS-rest, Task-specific PCMS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study welcome senior citizens to participate?
"The minimum age requirement for this study is 18 years old and the maximum allowed age is 80."
Answered by AI
Are any participants being recruited for this experiment at the present time?
"This particular medical trial is no longer seeking participants. It was initially listed on February 1st 2023, and its last update occurred in early 10th of the same month. Despite this, there are still a total of 1044 other trials currently recruiting patients."
Answered by AI
Could I possibly be included in this experiment?
"This clinical trial is currently seeking 40 people aged 18-80 who have suffered a stroke. The applicants must possess minimal wrist and finger extension, demonstrated by 5-20º active movement in each respective limb, be able to actively participate with a score of 23 or higher on the Mini Mental Status Exam, comprehend English language communication and demonstrate capacity for spherical grasping as indicated by at least 1 out of 2 on the Fugl Meyer Upper Extremity Subscale."
Answered by AI
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