Primed vs. Unprimed rTMS in Chronic Stroke

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

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 given alone and 2.) Primed rTMS will result in greater improvements of paretic hand function. This study is innovative in that it intends to compare primed and unprimed rTMS in the stroke brain that could acknowledge a more effective delivery method of rTMS to potentially yield greater rehabilitative outcomes.

Key facts

Study ID

NCT01757821

Run by

University of Minnesota

People needed

11

Starts

2013-04-01

Expected to finish

2014-07-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• presence of stroke at least six months duration
• demonstrate at least 10 degrees of active extension at the paretic index finger (metacarpophalangeal joint)
• possess resting motor evoked potential on the stroke hemisphere with TMS testing
• Upper Extremity Fugl Meyer score at least 20 out of 66
• Beck Depression Inventory equal to or less than 19 out of 63
• Mini-Mental State Examination score at least 24 out of 30
• age-appropriate receptive language ability

You may not qualify if…

• history of seizure within the last two years
• indwelling metal or medical devices incompatible with TMS
• anosognosia
• pregnancy
• any co-morbidities impairing upper extremity function (e.g. fracture)

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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