Fatiguing Arm Exercise Following Stroke

NCT03194464 | Completed Results

• 1 other identifier: N1759-P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue) with the less involved, or so-called non-paretic hand, in people who have experienced a stroke. In previous work the investigators found that non-paretic hand exercise to task-failure increased excitability of the motor cortex in the more involved hemisphere and produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude of increased brain excitability is greater than what has been observed following brain stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the clinical setting and could be accessible to a greater number of people than brain stimulation. The investigators' goals in the current study are to: repeat previous findings in a different group of participants and investigate the neural mechanisms that produce brain and behavioral facilitation in order to inform development of this approach for clinical implementation.

Conditions

Stroke

Keywords

hemiparesis

Outcome Measures

Primary Outcomes (2)

• Short Intracortical Inhibition (SICI)

  SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values \<1 reflect inhibition and \>1 disinhibition or relative excitation. In health, SICI is \~0.5. Thus if SICI = 0.8, while \<1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.

  baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)

• SICI Ratio

  SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values \<1 reflect inhibition and \>1 disinhibition or relative excitation. In health, SICI is \~0.5. Thus if SICI = 0.8, while \<1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.

  Baseline, pre-exercise of 8 repeated sessions

Other Outcomes (2)

• Box and Blocks Test (BBT)

  baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)

• Box and Blocks Test (BBT)

  baseline, pre-exercise of 8 repeated sessions

Study Arms (1)

Task-failure, Extended Session

EXPERIMENTAL

Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period

Other: submaximal exercise (grip)

Interventions

submaximal exercise (grip) OTHER

participants perform repeated gripping with visual feedback to task failure

Task-failure, Extended Session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
• Non-Veteran Participants are eligible

You may not qualify if:

• multiple strokes
• strokes in both hemispheres
• brainstem/medullary/cerebellar stroke
• seizure disorder
• metal implants in head or neck
• pacemaker or other implanted device
• inability to produce any measurable grip force

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

This was designed and intended as a small, pilot study to establish feasibility, refine methods, and generate preliminary data that could motivate sample size projections for future study.

Results Point of Contact

• Title: Dr. Carolynn Patten (Principal Investigator)
• Organization: VA Northern California Health Care System

carolynn.patten@va.gov

916.724.5029

Study Officials

• Carolynn Patten, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective, repeated measures

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: June 21, 2017
• Study Start: February 1, 2016
• Primary Completion: May 21, 2018
• Study Completion: May 21, 2018
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)