Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01575366
First received: March 19, 2012
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

Aim 1. Determine whether higher-velocity finger tracking training improves hand function more than slower velocity training. Working hypotheses: The higher-velocity training will have significantly greater functional improvement compared to the lower-velocity training, as measured by standardized upper extremity functional tests (Jebsen Taylor test, Box & Block Test, and Finger extension force test)

Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces cortical reorganization as compared to lower-velocity finger tracking training.

Working hypotheses: The higher-velocity training will have significantly greater cortical reorganization compared to the lower-velocity training, as measured by:

  1. TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area (M1).
  2. fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional M1.

Aim 3. Explore whether the functional improvements correlate with the cortical reorganization. Working hypotheses: The functional improvements will correlate with the cortical reorganization.


Condition Intervention Phase
Stroke
Behavioral: Tracking training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Hand function improvement [ Time Frame: taken at weekly intervals for the whole study length, 20 weeks. ] [ Designated as safety issue: No ]
    Jebsen Taylor test, Box & Block Test, and Finger extension force test


Secondary Outcome Measures:
  • corticospinal excitability [ Time Frame: taken at weekly intervals for the whole study length, 20 weeks. ] [ Designated as safety issue: No ]
    TMS

  • cognitive function [ Time Frame: at the beginning and at the end of the study, which are 1st and 20th week. ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Slow tracking training Behavioral: Tracking training
The paretic finger movement training at different velocities included two 5-week periods of five days per week, 2-hours per day phases. The frequency for the higher-velocity training is 0.8 Hz, whereas the lower frequency training is 4 times slower, at 0.2 Hz. The two periods are each followed by a 3-week baseline period. The subject is seated in front of a laptop computer with the paretic forearm resting on the arm of the chair in a quiet room at home. The position of the forearm is pronated. An electrogoniometer, composed of a potentiometer attached to a custom hand splint, is placed on the paretic index finger with the potentiometer centered at the metacarpophalangeal joint. To keep the training session time equal between the two training phases, the duration of each slow training trial is 5 sec, compared to 20 sec for each fast training trial. Ultimately, the total number of required finger extension/flexion training movements is equal between the two phases.
Experimental: Fast tracking training Behavioral: Tracking training
The paretic finger movement training at different velocities included two 5-week periods of five days per week, 2-hours per day phases. The frequency for the higher-velocity training is 0.8 Hz, whereas the lower frequency training is 4 times slower, at 0.2 Hz. The two periods are each followed by a 3-week baseline period. The subject is seated in front of a laptop computer with the paretic forearm resting on the arm of the chair in a quiet room at home. The position of the forearm is pronated. An electrogoniometer, composed of a potentiometer attached to a custom hand splint, is placed on the paretic index finger with the potentiometer centered at the metacarpophalangeal joint. To keep the training session time equal between the two training phases, the duration of each slow training trial is 5 sec, compared to 20 sec for each fast training trial. Ultimately, the total number of required finger extension/flexion training movements is equal between the two phases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria include:

  • Ischemic stroke - due to higher risk of seizures in hemorrhagic stroke
  • Subcortical location of stroke
  • Stroke after 6 months - lower limit of 6 months to avoid confounding from spontaneous recovery (Jorgensen, Nakayama et al. 1995) and no upper limit to maximize pool of candidate subjects while still showing training effect (Carey, Kimberley et al. 2002)
  • At least 18 years of age - to maximize pool of candidate subjects
  • Mini-Mental State Examination score >24 - to ensure satisfactory cognition to perform tasks
  • Satisfactory corrected vision - to see computer screen during training and testing
  • Active range of MP joint at paretic index finger of at least 10 degrees - based on minimal movement required to perform training task successfully, and that larger amplitudes would reduce the pool of subjects available for participating in the study.
  • Ability to pronate the forearm so that index finger extension movement during training is vertically upward and relaxation results in the finger falling back to the flexed starting position
  • not currently receiving any other therapy - to avoid confounding treatment effects
  • Approval for participation by a neurologist - to ensure subject is reasonably safe to receive TMS testing. Subjects with proprioceptive loss or expressive aphasia will be included, providing they can carryout the training task.

Exclusion criteria include:

  • Inability to follow 3-step commands
  • A visual field cut that causes subjects not to see all indicators on a computer screen positioned centrally in from of them
  • History of seizures
  • Family member with history of seizures
  • Presence of any other neuromuscular disorders
  • Pregnancy
  • Claustrophobia
  • Indwelling metal or medical devices/implants incompatible with functional fMRI testing
  • History of exposure to finger tracking training.
  • Informed consent will be obtained and TMS/fMRI safety screenings will be conducted prior to testing procedures.
  • Subjects will be recruited as volunteers from letters sent to previous research subjects inviting their participation, through visits to local stroke support groups meetings, newspaper advertisements and referrals from neurologists.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01575366

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Huiqiong Deng, MD, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01575366     History of Changes
Other Study ID Numbers: Movement Velocity Effect
Study First Received: March 19, 2012
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

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 September 30, 2014