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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938690
• Other study ID #: R-758-12
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2021
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial magnetic stimulation (TMS)
8 sessions of TMS followed by task specific training

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper limb function (Fugl Meyer score)		6 months