Modulating Interaction of Motor Learning Networks in Rehabilitation of Stroke

NCT03086551 | Completed Results DMC FDA Device

• 1 other identifier: 1R03NS096484-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a form on non-invasive brain stimulation called transcranial magnetic stimulation to understand 1) understand how the brain learns post-stroke and 2) assess non-invasive brain stimulation as an addition to current stroke rehabilitation approaches. In two study arms the investigators will compare the effect of active transcranial magnetic stimulation paired with motor practice with placebo (or sham) transcranial magnetic stimulation paired with the same motor practice.

Conditions

Stroke; Stroke, Chronic; Stroke, Middle Cerebral Artery With Infarction

Keywords

Transcranial Magnetic Stimulation; Motor Impairment; Rehabilitation; Motor Learning

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Sequential Response Time to Post-Intervention

  Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability.

  Baseline and post-intervention

Secondary Outcomes (4)

• Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test

  Baseline and post-intervention

• Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)

  Within session baseline to ~8 minutes post-application of non-invasive stimulation within the same session

• Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention

  Baseline and post-intervention

• Change From Baseline in Cortical Excitability Post-Intervention

  Baseline and post-intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Application of active continuous theta burst stimulation over dorsolateral prefrontal cortex prior to upper limb motor practice.

Device: Active continuous theta burst stimulation (cTBS); Behavioral: Motor Practice

Control

PLACEBO COMPARATOR

Application of sham continuous theta burst stimulation over dorsolateral prefrontal cortex prior to upper limb motor practice.

Device: Placebo (Sham) continuous theta burst stimulation; Behavioral: Motor Practice

Interventions

Active continuous theta burst stimulation (cTBS) DEVICE

Active cTBS over dorsolateral prefrontal cortex that has an effect upon dorsolateral prefrontal cortex brain activity.

Experimental

Placebo (Sham) continuous theta burst stimulation DEVICE

Sham stimulation over dorsolateral prefrontal cortex that looks and sounds like active cTBS but does not have any effect upon dorsolateral prefrontal cortex brain activity.

Control

Motor Practice BEHAVIORAL

Upper limb reaching task to be practiced. Practice will be paired with Active/Sham stimulation. Twenty trials will occur before Active/Sham stimulation. 40 trials will be practiced after Active/Sham stimulation.

Control; Experimental

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50-75 years
• movement-related deficit associated with first time middle cerebral artery stroke
• greater than 6-months post-stroke
• Fugl-Meyer score between 15 and 60
• ability to elicit a motor evoked potential from the ipsilesional cortex

You may not qualify if:

• a score \<27 on the Mini-Mental Status Exam
• a score of \<123 on the Mattis Dementia Rating Scale
• a score of \<13 on the Frenchay Aphasia Screen
• a history of seizure/epilepsy, head trauma, major psychiatric diagnosis, neurodegenerative disorder or substance abuse
• a history of congestive heart failure
• systolic blood pressure above 120 mmHg and/or diastolic pressure above 80 mmHg
• the taking of any GABAergic, NMDA-receptor antagonist or other drug known to influence the neural receptors that facilitate neural plasticity
• an infarct resulting from ischemic stroke of anterior or posterior cerebral artery OR an infarct that encroaches within 2cm of the site of cTBS stimulation
• absence of an MEP in response to single pulse transcranial magnetic stimulation over ipsilesional M1 and 10) any other contraindication to TMS or MRI.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Human Sensorimotor Laboratory, School of Kinesiology, University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Related Publications (3)

• Meehan SK, Randhawa B, Wessel B, Boyd LA. Implicit sequence-specific motor learning after subcortical stroke is associated with increased prefrontal brain activations: an fMRI study. Hum Brain Mapp. 2011 Feb;32(2):290-303. doi: 10.1002/hbm.21019.

  PMID: 20725908 BACKGROUND

• Meehan SK, Dao E, Linsdell MA, Boyd LA. Continuous theta burst stimulation over the contralesional sensory and motor cortex enhances motor learning post-stroke. Neurosci Lett. 2011 Aug 1;500(1):26-30. doi: 10.1016/j.neulet.2011.05.237. Epub 2011 Jun 12.

  PMID: 21683125 BACKGROUND

• Brodie SM, Meehan S, Borich MR, Boyd LA. 5 Hz repetitive transcranial magnetic stimulation over the ipsilesional sensory cortex enhances motor learning after stroke. Front Hum Neurosci. 2014 Mar 21;8:143. doi: 10.3389/fnhum.2014.00143. eCollection 2014.

  PMID: 24711790 BACKGROUND

Related Links

• Primary Investigator's Profile Page

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Sean K Meehan, PhD
• Organization: University of Waterloo, Waterloo, Ontario, Canada

skmeehan@uwaterloo.ca

5198884567

Study Officials

• Sean K Meehan, PhD

  Sch. of Kinesiology, Univ. of Michigan

  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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2016
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)