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NCT01757821 · ClinicalTrials.gov registry record · NA

Primed vs. Unprimed rTMS in Chronic Stroke

A NA study of Stroke, sponsored by University of Minnesota.

Completed
Registry status
NA
Development phase
11
Enrollment target
1
Study location

NCT01757821 is a NA study of Stroke that has completed, run by University of Minnesota. The registered enrollment target is 11 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01757821, a NA study of Stroke, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

The goal of stroke rehabilitation is to restore function to the weak side of the body. However, this is often a difficult task to accomplish due to not only to damage from the stroke, but from increased excitability in the non-stroke side of the brain that inhibits the stroke side from functioning optimally. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation that can enhance excitability in the stroke side when applied at a low-frequency on the non-stroke side. By "inhibiting the inhibition" (i.e. disinhibition), rTMS promotes adaptive brain reorganization following stroke. Previous research in healthy individuals demonstrates enhanced effects of low-frequency rTMS when it is preceded by high-frequency (excitatory) rTMS stimulation known as priming. Our lab previously demonstrated the safety of 6-Hz priming with low-frequency rTMS in both adults and children with chronic stroke. However, it is currently unknown whether or not the addition of priming stimulation to low-frequency rTMS enhances excitability in the stroke hemisphere. Our study will examine three rTMS interventions in twelve adults (at least 18 years): 1.) 10 minutes of real priming followed by 10 minutes of low-frequency rTMS, 2.) 10 minutes of fake priming followed by 10 minutes of low-frequency rTMS, 3.) 20 minutes of low-frequency rTMS only. Participants will receive all three interventions in randomized order. Each week, participants will complete two pretest and 3 posttest sessions consisting of behavioral measures of weak upper extremity function and cortical excitability in addition to receiving one rTMS intervention. Following each week of testing and treatment, subjects will take a one week rest break before crossing-over to receive another intervention. We hypothesize the following: 1.) Primed rTMS will result in significantly reduced inhibition and significantly increased excitation on the stroke side vs. fake primed rTMS or low-frequency rTMS give

Conditions Studied

Stroke

Interventions

  • DEVICE real 6-Hz primed low-frequency rTMS
  • DEVICE Sham 6-Hz Primed low-frequency rTMS
  • DEVICE real 1-Hz rTMS only

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2013-04
Est. Completion 2014-07
Phase NA

Sponsor

University of Minnesota

966 total trials

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What the Registry Record Tells You About NCT01757821

The ClinicalTrials.gov registry entry for NCT01757821 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 3 interventions - of which real 6-Hz primed low-frequency rTMS is the first listed.

NCT01757821 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT01757821 about?

NCT01757821 is a clinical study titled "Primed vs. Unprimed rTMS in Chronic Stroke". The goal of stroke rehabilitation is to restore function to the weak side of the body. However, this is often a difficult task to accomplish due to not only to damage from the stroke, but from increased excitability in the non-stroke side of the brain that inhibits the stroke side from functioning o...

What is the current status of trial NCT01757821?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2013-04. Estimated completion is 2014-07.

What conditions does trial NCT01757821 study?

This clinical trial studies the following conditions: Stroke.

What interventions are being tested in trial NCT01757821?

The interventions under investigation include: real 6-Hz primed low-frequency rTMS (DEVICE), Sham 6-Hz Primed low-frequency rTMS (DEVICE), real 1-Hz rTMS only (DEVICE).

Who is sponsoring clinical trial NCT01757821?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01757821 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.