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NCT01049802 · ClinicalTrials.gov registry record · Phase 1
Contrastim Stroke Trial
A Phase 1 study, sponsored by Shirley Ryan AbilityLab.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01049802 is a Phase 1 study that has completed, run by Shirley Ryan AbilityLab. The registered enrollment target is 30 participants.
The verdict
NCT01049802, a Phase 1 study, has completed, sponsored by Shirley Ryan AbilityLab.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.
Interventions
- DEVICE Repetititve transcranial magnetic stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01049802
The ClinicalTrials.gov registry entry for NCT01049802 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shirley Ryan AbilityLab, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Repetititve transcranial magnetic stimulation is the first listed.
NCT01049802 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01049802 about?
NCT01049802 is a clinical study titled "Contrastim Stroke Trial". This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation ...
What is the current status of trial NCT01049802?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-01. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01049802?
The interventions under investigation include: Repetititve transcranial magnetic stimulation (DEVICE).
Who is sponsoring clinical trial NCT01049802?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
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