Repetitive Transcranial Magnetic Stimulation (rTMS) to Contralesional Hemisphere in Patients With Stroke for Upper Limb Recovery (ContraStim)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nexstim Ltd
Information provided by (Responsible Party):
Richard Harvey, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01049802
First received: January 13, 2010
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

This is a prospective randomized controlled feasibility study to determine whether navigation guided repetitive transcranial magnetic stimulation (rTMS) to the healthy hemisphere in patients with subacute stroke has a beneficial effect when given concurrently with task-oriented motor rehabilitation of the arm and hand. Navigation guided rTMS requires a structural MRI scan for targeting stimulation and therefore structural MRI will be performed on all subjects. In addition the study intends to determine whether measures of motor tract integrity (MTI) assessed by navigated brain stimulation (NBS) and MRI diffusion tensor imaging can be used to clarify prognosis of motor recovery and to monitor progress with rehabilitation. 30 subjects with ischemic or hemorrhagic stroke 3-9 months prior to enrollment and with residual upper limb hemiplegia will be randomized to receive either 1 Hz rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy or sham rTMS to the contralesional hemisphere for 30 minutes 3 times a week for 6 weeks along with rehabilitation therapy. Primary outcome is improvement on the Action Research Arm Test, a measure of arm and hand function in people with stroke. Outcomes will be measured immediately post treatment, and at 3 months and 6 months post treatment.


Condition Intervention Phase
Stroke
Device: repetitive transcranial magnetic stimulation to contralesional hemisphere
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Therapeutic Effects of Navigation-guided 1 Hz rTMS Administered to the Contralesional Hemisphere in Patients With Stroke

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Action Research Arm Test [ Time Frame: Baseline, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fugl-Meyer Score [ Time Frame: Baseline, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Baseline, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]
  • Chedoke Arm and Hand Inventory [ Time Frame: Screening, baseline, weekly, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: Screening, Baseline, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]
  • NIH Stroke Scale [ Time Frame: Screening, baseline, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]
  • Motor evoked response using TMS [ Time Frame: Baseline, weekly, post treatment, 1 month, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contralesional rTMS with arm rehabilitation
Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.
Device: repetitive transcranial magnetic stimulation to contralesional hemisphere
1 Hz rTMS to contralesional hemisphere in patients with stroke
Placebo Comparator: Sham contralesional rTMS plus arm rehabilitation
Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb
Device: repetitive transcranial magnetic stimulation to contralesional hemisphere
1 Hz rTMS to contralesional hemisphere in patients with stroke

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study
  • no other known brain abnormalities by history or by structural MRI
  • A one-sided stroke resulting in upper extremity paresis
  • A Chedoke Arm and Hand Activity Inventory score of 3-6 for the affected limb

Exclusion Criteria:

  • Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump
  • Pregnant or trying to become pregnant
  • History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
  • any history of epilepsy
  • Any condition that would prevent the subject from giving voluntary informed consent
  • An implanted brain stimulator
  • Aneurysm clip or other metal in body
  • Enrolled or plans to enroll in an interventional trial during this study
  • Scalp wounds or infections
  • Claustrophobia precluding MRI
  • A fixed contraction deformity in the affected limb
  • Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in the affected limb
  • previous stroke with residual deficits (TIAs not a reason for exclusion)
  • premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology
  • a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition
  • confirmed or suspected lower-limb fracture preventing mobilization
  • patients requiring palliative care
  • patients undergoing any other occupational therapy than what is provided in the study
  • A recent injection of botulinum toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up
  • Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale
  • Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale
  • Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049802

Locations
United States, Illinois
The Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Nexstim Ltd
Investigators
Principal Investigator: Richard L Harvey, MD The Rehabilitation Institute of Chicago
Study Director: Jarmo Laine, MD, PhD, MBA Nexstim Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Harvey, Medical Director of Stroke Rehabilitation, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01049802     History of Changes
Other Study ID Numbers: NR-001
Study First Received: January 13, 2010
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
stroke
hemiplegia
TMS

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014