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

NCT01938690 | Completed DMC

• 1 other identifier: R-758-12
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke, transcranial magnetic stimulation, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Upper limb function (Fugl Meyer score)

  6 months

Study Arms (2)

Sham stimulation

SHAM COMPARATOR

Sham stimulation on the scalp of unaffected brain

Device: Transcranial magnetic stimulation (TMS)

transcranial magnetic stimulation

EXPERIMENTAL

transcranial magnetic stimulation on unaffected brain

Device: Transcranial magnetic stimulation (TMS)

Interventions

Transcranial magnetic stimulation (TMS) DEVICE

8 sessions of TMS followed by task specific training

Sham stimulation; transcranial magnetic stimulation

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• A.M. Barrett, MD

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Stroke Lab

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)