Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke

NCT01922986 | Completed Results DMC

• 1 other identifier: Acute_rTMS
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

When a certain area of the brain is injured, like in stroke, several events occur. One side of the body may become weak. This weakness is called hemiparesis and it may create difficulty in performing tasks like writing, eating, and walking. The weakness results from two sources:

1. 1.death of some brain cells in the affected side (hemisphere) of the brain
2. 2.exaggerated inhibitory signals from the unaffected hemisphere acting on surviving neurons in the affected hemisphere.

Conditions

Stroke

Keywords

stroke; rehabilitation; hemiplegia; repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores

  This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests

  Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).

Secondary Outcomes (2)

• Change in Finger Tracking Test

  Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).

• Change in Motricity Index

  Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).

Study Arms (2)

Active rTMS with conventional therapy

EXPERIMENTAL

20 minutes of active rTMS followed by conventional stroke therapy

Device: active rTMS; Behavioral: conventional stroke therapy

sham rTMS with conventional therapy

SHAM COMPARATOR

20 minutes of sham rTMS stimulation followed by conventional stroke therapy

Device: sham rTMS; Behavioral: conventional stroke therapy

Interventions

active rTMS DEVICE

10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).

Active rTMS with conventional therapy

sham rTMS DEVICE

20 minutes of sham rTMS stimulation

sham rTMS with conventional therapy

conventional stroke therapy BEHAVIORAL

conventional stroke therapy consisting of exercises and physical training

Active rTMS with conventional therapy; sham rTMS with conventional therapy

Eligibility Criteria

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

You may qualify if:

• stroke onset: within past 30 days but rTMS intervention will commence no sooner than 5 days from stroke onset
• stroke location: cortical or subcortical
• stroke type: ischemic
• age: \>18 years
• paretic index finger must show either no or impaired flexion/extension motion at the metacarpophalangeal (MP) joint.
• Mini-Mental State Examination greater than or equal to 22
• ability to stand/transfer with no more than moderate assistance

You may not qualify if:

• seizure within past two years
• metal in head (dental permitted)
• pregnancy
• psychiatric disorders
• receiving tricyclic antidepressants or neuroleptics
• inability to follow three-step command
• hemineglect
• dependent on ventilator, nasogastric tube, or implanted medical device
• co-morbidities impairing upper extremity function
• anticipated stay at Courage Kenny Rehabilitation Institute shorter than 7 treatment days

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Courage Kenny Rehabilitation Institute

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrollment of subjects was insufficient.

Results Point of Contact

• Title: James R. 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 14, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 25, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)