Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke

• ClinicalTrials.gov Identifier: NCT01575366
• Recruitment Status: Completed
• First Posted: April 11, 2012
• Last Update Posted: November 1, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Stroke	Behavioral: Tracking training	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke
• Study Start Date: February 2010
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Hand function improvement [ Time Frame: taken at weekly intervals for the whole study length, 20 weeks. ]
   Jebsen Taylor test, Box & Block Test, and Finger extension force test

Secondary Outcome Measures :

1. corticospinal excitability [ Time Frame: taken at weekly intervals for the whole study length, 20 weeks. ]
   TMS
2. cognitive function [ Time Frame: at the beginning and at the end of the study, which are 1st and 20th week. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Huiqiong Deng, MD, MS; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01575366
• Other Study ID Numbers: 0912M74993
• First Posted: April 11, 2012
• Last Update Posted: November 1, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

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