NCT01726218

Brief Summary

It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite of the body. However, it is not clear whether as the movement becomes more complicated, the motor cortex of both hemispheres of the brain are involved. Currently the role of the motor cortex on the same side of the body (referred to as ipsilateral motor cortex) in hand performance remains controversial. The investigators demonstrated previously in healthy subjects that transiently lowering the activity of ipsilateral motor cortex improved the performance of the opposite hand. What is not know are the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS) is a device that allows the non- invasive stimulation of the brain. When brain is stimulated repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain area becomes less active. This effect lasts 10 minutes and is called a "transient artificial lesion" as it mimicks the effects of transiently interfering with the function of the stimulated brain area. In the present study the investigators will conduct experiments using repetitive TMS to downregulate the activity of the motor area as in previous experiments and measures its effect on activity of motor cortex of both hemispheres. The investigators will study healthy subjects. It would be important to understand the effects in more detail for the design of treatment strategies in patients after stroke, which will be a topic of future studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2015

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

3.9 years

First QC Date

March 29, 2012

Last Update Submit

October 12, 2018

Conditions

Keywords

StrokePhysical Medicine & RehabilitationNeurologyNeurophysiologyNeuroscienceTranscranial Magnetic Stimulation (TMS)

Outcome Measures

Primary Outcomes (1)

  • Define key parameters that contribute to contralesional M1 reorganization following stroke

    Up to six months post-stroke

Study Arms (2)

Stroke patients

Healthy Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 Stroke patients with 15 in each group based on location of stroke 50 healthy volunteers

You may qualify if:

  • Age 18-80
  • Single cerebral ischemic infarction one month prior to entering study
  • Affecting only one hemisphere as defined by MRI of the brain
  • At the time of cerebral infarct a motor deficit of hand of Medical Research Council Scale for Muscle Strength (MRC) of \< 4- of wrist and finger extension/flexion movement
  • Fugl Meyer score \> 27/66 (motor domain, upper extremity)
  • Ability to operate joystick at largest target level
  • No other neurological disorder
  • No intake of Central Nervous System (CNS) active drugs
  • Ability to give informed consent
  • No major cognitive impairment
  • Age 55-80 years with no neurological or psychiatric diseases
  • Normal neurological examination
  • Normal MRI of the brain
  • Normal neuropsychological testing
  • No intake of CNS active drugs that interfere with data collection
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Wischnewski M, Edwards L, Revill KP, Drake D, Hobbs G, Buetefisch CM. Intensity-Dependent Effects of Low-Frequency Subthreshold rTMS on Primary Motor Cortex Excitability and Interhemispheric Inhibition in Elderly Participants: A Randomized Trial. Neurorehabil Neural Repair. 2025 Jan;39(1):58-73. doi: 10.1177/15459683241292615. Epub 2024 Oct 27.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cathrin Buetefisch, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Cathrin Buetefisch, M.D., PhD

Study Record Dates

First Submitted

March 29, 2012

First Posted

November 14, 2012

Study Start

May 1, 2011

Primary Completion

March 26, 2015

Study Completion

March 26, 2015

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations