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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation (TMS)

Device

8 sessions of TMS followed by task specific training

Primary outcomes

Upper limb function (Fugl Meyer score)

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

Effect of Transcranial Magnetic Stimulation on Motor Recovery of Upper Limb Among Stroke Survivors: Pilot Study

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Sep 10, 2013
Registry last updated: Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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