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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (TMS)
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, transcranial magnetic stimulation, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham stimulation

transcranial magnetic stimulation

Arm Description

Sham stimulation on the scalp of unaffected brain

transcranial magnetic stimulation on unaffected brain

Outcomes

Primary Outcome Measures

Upper limb function (Fugl Meyer score)

Secondary Outcome Measures

Full Information

First Posted
September 5, 2013
Last Updated
February 16, 2021
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01938690
Brief Title
Effect of Transcranial Magnetic Stimulation on Recovery of Upper Limb Among Stroke Survivors
Official Title
Effect of Transcranial Magnetic Stimulation on Motor Recovery of Upper Limb Among Stroke Survivors: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
See above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, transcranial magnetic stimulation, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation on the scalp of unaffected brain
Arm Title
transcranial magnetic stimulation
Arm Type
Experimental
Arm Description
transcranial magnetic stimulation on unaffected brain
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
8 sessions of TMS followed by task specific training
Primary Outcome Measure Information:
Title
Upper limb function (Fugl Meyer score)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.M. Barrett, MD
Organizational Affiliation
Kessler Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

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

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