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NCT03868410 · ClinicalTrials.gov registry record · Early Phase 1
A Novel Approach for Brain Stimulation in Severe Stroke
A Early Phase 1 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT03868410: Completed Early Phase 1 study, sponsored by The Cleveland Clinic.
NCT03868410 is a Early Phase 1 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03868410, a Early Phase 1 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb. This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks. The study will include the following site visits: * Eligibility Screening and Informed Consent Visit * An MRI visit * Two testing visits in which motor function of the upper limb and neurophysiology will be measured * 12 intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation * Repeat testing of motor function of the upper limb and neurophysiology * Repeat MRI testing * A follow-up visit completed 3 months after the completion of interventions
Primary Outcome
Change between Baseline and Post-Test (average 6 weeks) is reported for the UEFM. Impairment will be measured using UEFM, one of the most widely used assessments in stroke. UEFM will serve as our primary outcome because it is sensitive to discerning the effects of rTMS/rehabilitation, and has excellent reliability (ICC= 0.97), consistency (Cronbach's α= 0.84) and validity. UEFM has a score ranging from 0-66 (0 meaning there is no movement of the paretic arm, and 66 meaning there is no functional
Interventions
- DEVICE New Repetitive Magnetic Stimulation (rTMS) Approach
- DEVICE Conventional Repetitive Magnetic Stimulation (rTMS) Approach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2023-07-13 |
| Phase | Early Phase 1 |
What the finished NCT03868410 record still lists
NCT03868410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which New Repetitive Magnetic Stimulation (rTMS) Approach is the first listed.
NCT03868410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03868410 about?
NCT03868410 is a clinical study titled "A Novel Approach for Brain Stimulation in Severe Stroke". The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb. This study will utilize a novel method of non-invasive brain stimulation in co...
What is the current status of trial NCT03868410?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2019-04-01. Estimated completion is 2023-07-13.
What interventions are being tested in trial NCT03868410?
The interventions under investigation include: New Repetitive Magnetic Stimulation (rTMS) Approach (DEVICE), Conventional Repetitive Magnetic Stimulation (rTMS) Approach (DEVICE).
Who is sponsoring clinical trial NCT03868410?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03868410's enrollment target sits among peer trials
16 1370th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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