Clinical trial NCT03194464: Fatiguing Arm Exercise Following Stroke
Official title: Neural Mechanisms Mediating Interlimb Transfer Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: hemiparesis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, repeated measures
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.

The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:

1. . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
2. . Behavioral effects using a motor task involving manipulation and dexterity.
3. . Determine the persistence and consistency of neural and behavioral facilitation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Short Intracortical Inhibition (SICI)
timeFrame: baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
measure: SICI Ratio
timeFrame: Baseline, pre-exercise of 8 repeated sessions
Secondary outcomes:
Other outcomes:
measure: Box and Blocks Test (BBT)
timeFrame: 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)
measure: Box and Blocks Test (BBT)
timeFrame: baseline, pre-exercise of 8 repeated sessions
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Carolynn Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References: