Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke

The University of Alabama at Birmingham

Status: Terminated

Conditions: Stroke; Hemiparesis; Hemiplegia

Treatments: Combination Product: iTBS&eCIMT

Study type: Interventional

Funder types: Other

Identifiers

NCT03538795

IRB-170530008

Details and patient eligibility

About

This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.

Full description

The overarching goal of this program of research is to develop a therapy that produces meaningful and persistent improvements in function of the more-affected arm in stroke survivors with severe, chronic hemiparesis. No treatment with an established evidence base is available now for this large group, who have barely perceptible voluntary movement of the more-affected fingers and wrist. The lab of E. Taub and G. Uswatte has developed an expanded version of Constraint-Induced Movement therapy (CIMT) for this population that has evidence of efficacy for improving use in daily life of the more-affected arm from a case series and small randomized controlled trial (RCT). The original version of CIMT is a form of physical rehabilitation that has evidence of efficacy from multiple RCTs for improving use in daily life of the more-affected arm in adults with mild to moderate hemiparesis after stroke. CIMT has also been shown to produce neuroplastic changes in both grey and white matter structures. Expanded CIMT (eCIMT) combines CIMT with neurodevelopmental techniques (NDT) for managing tone. Studies from by J. Szaflarski and by others suggest that priming CNS tissue for training by electrically stimulating the brain regions that control the target function with excitatory intermittent theta burst stimulation (iTBS) augments the benefits of neurorehabilitation. This pilot study will evaluate the feasibility of combining eCIMT with brain stimulation by iTBS and, on a preliminary basis, will evaluate whether this combination therapy boosts treatment outcomes relative to eCIMT alone.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stroke
• > 12 months after stroke onset
• severe hemiparesis of more-affected arm

Exclusion criteria

• substantial use of the more-affected arm in daily life
• frailty or insufficient stamina to carry out the requirements of the therapy
• other neurological or musculoskeletal problems, including pain, affecting the more-affected arm
• severe cognitive deficits

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

iTBS&eCIMT

Experimental group

Description:

Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS\&eCIMT, and then receive post-treatment testing.

Treatment:

Combination Product: iTBS&eCIMT