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Contrastim Stroke Trial (ContraStim)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01049802
First Posted: January 14, 2010
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nexstim Ltd
Information provided by (Responsible Party):
Richard Harvey, Rehabilitation Institute of Chicago
  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: Repetititve transcranial magnetic stimulation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Richard Harvey, Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Upper Extremity Fugl-Meyer Score [ Time Frame: Baseline, post treatment, 1 month, 6 months ]
    Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)


Secondary Outcome Measures:
  • Action Research Arm Test [ Time Frame: Baseline, post treatment, 1 month, 6 months ]

    The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:

    • 3: Performs test normally
    • 2: Completes test, but takes abnormally long or has great difficulty
    • 1: Performs test partially
    • 0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity

  • Stroke Impact Scale [ Time Frame: Baseline, post treatment, 1 month, 6 months ]

    The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure

    • 8 domains assessed:

      • Strength (4 items)
      • Hand function (5 items)
      • ADL/IADL (10 items)
      • Mobility (9 items)
      • Communication (7 items)
      • Emotion (9 items)
      • Memory and thinking (7 items)
      • Participation/Role function (8 items)
    • Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item
    • Summative scores are generated for each domain, scores range from 0-100

  • Chedoke Arm Assessment [ Time Frame: Screening, baseline, weekly, post treatment, 1 month, 6 months ]
    A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.

  • NIH Stroke Scale [ Time Frame: Screening, baseline, post treatment, 1 month, 6 months ]

    A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale

    • 15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity
    • Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment
    • Scores range from 0 - 42. Higher scores indicate greater severity.
    • Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):

      • Very Severe: >25
      • Severe: 15 - 24
      • Mild to Moderately Severe: 5 - 14
      • Mild: 1 - 5


Enrollment: 30
Study Start Date: January 2010
Study Completion Date: September 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active rTMS
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: Repetititve transcranial magnetic stimulation
1 Hz rTMS to contralesional hemisphere in patients with stroke
Placebo Comparator: Sham rTMS
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: Repetititve transcranial magnetic stimulation
1 Hz rTMS to contralesional hemisphere in patients with stroke

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049802


Locations
United States, Illinois
The Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
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:
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
First Submitted: January 13, 2010
First Posted: January 14, 2010
Results First Submitted: July 31, 2015
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016

Keywords provided by Richard Harvey, Rehabilitation Institute of Chicago:
stroke
hemiplegia
TMS

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