Primed vs. Unprimed rTMS in Chronic Stroke

NCT01757821 | Completed Results DMC

• 1 other identifier: BrainPrime
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke

Keywords

Stroke; rTMS; TMS

Outcome Measures

Primary Outcomes (1)

• Change in Cortical Excitability: Paired-Pulse

  Cortical Excitability of the primary motor cortex on the stroke hemisphere will be assessed using paired-pulse transcranial magnetic stimulation.

  Change from Baseline to 20 minutes

Study Arms (3)

6-Hz Priming

EXPERIMENTAL

real 6-Hz primed low-frequency rTMS

Device: real 6-Hz primed low-frequency rTMS

Sham 6-Hz Priming

SHAM COMPARATOR

Sham 6-Hz Primed low-frequency rTMS

Device: Sham 6-Hz Primed low-frequency rTMS

Real 1-Hz rTMS only

ACTIVE COMPARATOR

real 1-Hz rTMS only

Device: real 1-Hz rTMS only

Interventions

real 6-Hz primed low-frequency rTMS DEVICE

10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region

6-Hz Priming

Sham 6-Hz Primed low-frequency rTMS DEVICE

10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region

Sham 6-Hz Priming

real 1-Hz rTMS only DEVICE

20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region

Real 1-Hz rTMS only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: James Carey
• Organization: University of Minnesota

carey007@umn.edu

612-626-2746

Study Officials

• James R Carey, PhD, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 31, 2012
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)