Clinical trial NCT03538795: Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke
Official title: Priming the Brain for Rehabilitation: Brain Stimulation Followed by Constraint-Induced Movement Therapy in Adults With Severe Arm Paresis After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiplegia
Hemiparesis
Keywords: stroke
hemiplegia
hemiparesis
arm
upper-extremity
motor impairment
transcranial magnetic stimulation (TMS)
brain stimulation
neuroplasticity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: NIH National Rehabilitation Research Resource to Enhance Clinical Trials
First posted: 2018-05-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series, with a no-treatment control period before the intervention
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: Change from Day 0 to Day 42
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: Change from Day 0 to Day 42
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from Day 0 to Day 42
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gitendra Uswatte, PhD
role: PRINCIPAL_INVESTIGATOR
References: