Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Transcranial Magnetic Stimulation on Recovery of Upper Limb Among Stroke Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938690
Recruitment Status : Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation

Brief Summary:
Approximately two thirds of stroke survivors have profoundly impaired function of the upper limb. Currently the main stay of the treatment for upper limb motor function is rehabilitation therapy focusing on repetitive and skillful task practice (task-oriented therapy) which has been shown to induce substantial functional reorganization in the undamaged motor cortex and functional recovery. In spite of rehabilitation therapy, functional recovery of arm and hand function is limited to one third of stroke survivors and there is a great need for adjunct treatment to current practice. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive means of stimulating nerve cells in superficial areas of the brain and emerging as a novel method of modulating cortical excitability and promoting functional recovery after stroke. There have been studies using rTMS to improve motor function after stroke. However, whether 1Hz rTMS can enhance the effect of the task-oriented therapy on upper limb function after stroke has not been investigated. In this pilot proposal, we intend to investigate the feasibility of 1Hz rTMS on unaffected hemisphere as an adjunct to task-oriented therapy to improve upper limb motor function among stroke patients. The information obtained from this pilot study will provide a platform for the future randomized control trials combining the rTMS and task-oriented therapy to enhance motor recovery among stroke survivors.

Condition or disease Intervention/treatment Phase
Stroke Device: Transcranial magnetic stimulation (TMS) Not Applicable

Detailed Description:
See above.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Magnetic Stimulation on Motor Recovery of Upper Limb Among Stroke Survivors: Pilot Study
Study Start Date : February 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Sham Comparator: Sham stimulation
Sham stimulation on the scalp of unaffected brain
Device: Transcranial magnetic stimulation (TMS)
8 sessions of TMS followed by task specific training

Experimental: transcranial magnetic stimulation
transcranial magnetic stimulation on unaffected brain
Device: Transcranial magnetic stimulation (TMS)
8 sessions of TMS followed by task specific training




Primary Outcome Measures :
  1. Upper limb function (Fugl Meyer score) [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

--≥18 years of age

  • Ability to give informed consent
  • An unilateral ischemic stroke of onset 6-36 months prior to the study
  • No other known brain abnormalities by medical history or by MRI
  • Affected upper limb function of score 2-6 in Chedoke Arm and Hand Inventory
  • Enrolled or planned to be enrolled in occupational therapy at Kessler Institute for Rehabilitation as an outpatient

Exclusion Criteria:

  • More than one stroke (Transient Ischemic Attack not a reason for exclusion) Neurological conditions other than stroke (brain tumor, Parkinson's disease, etc)
  • History of epilepsy or unprovoked seizures
  • Family history of epilepsy (father, mother, children, siblings with diagnosis of epilepsy)
  • Implanted medical devices (pacemakers, defibrillators, medical pump, implanted brain stimulator, aneurysm clip, carotid or cerebral stents, central venous catheter, cochlear implant, internal hearing aids)
  • Damaged skin or skull of head
  • Excessive spasticity of upper limb as indicated by Modified Ashworth Spasticity Scale >2/4
  • Recent injection of antispastic medications (Botulinum toxin, phenol) of the last 3 months or scheduled such injection during the study period
  • Severe sensory deficits as measured by a score of 2 on item 8 of the National Institute of Health (NIH) stroke scale
  • Severe aphasia as measured by a score of ≥2 on item 9 of NIH stroke scale
  • Being determined to be medically unstable by a physician
  • Being pregnant or trying to become pregnant
  • Past or current alcohol abuse, illicit drug use, or significant mental illness (schizophrenia, major depression, manic disorders)
  • Working with metal currently or in the past
  • Tattoo with metal based ink on the head or neck
  • Unable to answer the questionnaires in the consent form correctly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938690


Locations
Layout table for location information
United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
Investigators
Layout table for investigator information
Study Director: A.M. Barrett, MD Kessler Foundation

Layout table for additonal information
Responsible Party: A. M. Barrett, MD, Director Stroke Lab, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01938690     History of Changes
Other Study ID Numbers: R-758-12
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: April 2018

Keywords provided by A. M. Barrett, MD, Kessler Foundation:
stroke, transcranial magnetic stimulation, rehabilitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases