Motor and Neurophysiological Changes After Ischemic Conditioning in Individuals With Stroke

University of Illinois

Status: Active, not recruiting

Conditions: Stroke

Treatments: Device: Real Ischemic Conditioning; Device: Sham Ischemic Conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05906602

2022-1620

Details and patient eligibility

About

The goal of this clinical trial is to test ischemic conditioning (blood flow restriction) as a neuromodulatory technique to improve gait function in stroke. Neuromodulation is emerging as a promising adjunct strategy to facilitate changes in brain activity and improve motor behavior following a neurological injury such as stroke.

The main questions this trial aims to answer are:

• Can ischemic conditioning produce neuromodulatory changes in the lower limb primary motor cortex?
• Can ischemic conditioning be used as a neuromodulatory technique to improve strength, motor control, and gait speed in individuals with stroke when compared to sham ischemic conditioning?

Participants will take part in two sessions of ischemic conditioning where a cuff (similar to ones that measure blood pressure) will be placed around the thigh and inflated to one of two blood flow restriction pressures (real or sham). Each participant will experience measures of brain activity and motor behavior testing before and after both sessions (ischemic conditioning and sham ischemic conditioning).

Researchers will investigate ischemic conditioning as neuromodulation modality in stroke to see if ischemic conditioning can produce beneficial changes in brain activity and improvements on subsequent motor behavior tasks.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single, stroke > 6 months since onset
• Residual hemiparetic gait deficits (e.g., abnormal gait pattern)

Exclusion criteria

• Lesions affecting the brainstem or cerebellum
• Other neurological disorders that may interfere with motor function
• Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures
• Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE<21)), which could impede the understanding of the purpose of procedures of the study
• Botulinum toxin (Botox) treatments to the lower limb within the past 6 months
• Pregnant women
• Contraindications to transcranial magnetic stimulation (TMS) or ischemic conditioning (IC) (Listed below)

TMS General Exclusion Criteria:

• Previous adverse reaction to TMS
• Skull abnormalities or fractures
• Concussion within the last 6 months
• Unexplained, recurring headaches
• Implanted cardiac pacemaker
• Metal implants in the head or face
• History of seizures or epilepsy
• Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
• Current pregnancy

IC General Exclusion Criteria:

• History of thrombosis (i.e., blood clots) including venous thrombosis or deep vein thrombosis (DVT).
• Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., open wounds in the leg, bruising, nerve damage, etc.)
• Peripheral arterial grafts in the lower extremity
• History of uncontrolled hypertension
• History of peripheral vascular disease or hematological disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Ischemic Conditioning

Experimental group

Description:

While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform real ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.

Treatment:

Device: Real Ischemic Conditioning

Sham Ischemic Conditioning

Sham Comparator group

Description:

While seated, a rapid inflation cuff, similar to those used to measure blood pressure, will be placed around the paretic thigh to perform sham or fake ischemic conditioning. The pressure of the cuff will be increased for 5 minutes followed by no pressure for 5 minutes, repeated 5 times for a total of 50 minutes.

Treatment:

Device: Sham Ischemic Conditioning