Clinical trial NCT04000269: HD-tDCs to Improve Upper Extremity Function in Patients With Acute Middle Cerebral Artery Stroke
Official title: Pilot Study Using Targeted High Definition Transcranial Direct Current Stimulation to Promote Upper Extremity Motor Function in Patients With Subacute Middle Cerebral Artery (MCA) Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Middle Cerebral Artery Stroke
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot prospective double blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To determine if using targeted high definition transcranial direct current stimulation can improve upper extremity motor function in patients with subacute middle cerebral artery (MCA) stroke.

Detailed description: Current research suggests there may be potential benefit using high definition transcranial direct current stimulation in patients with upper extremity hemiparesis secondary to an ischemic stroke. The intervention has effects on the damaged neurons within the person's brain after stroke possibly amplifying the body's own healing process. These data are compelling but not always statistically significant, which could be due to several reasons. One is the lack of a definitive protocol involving timing of the intervention relative to therapy, lead placement, an unclear dose-response relationship, and variable conductance of tissue and skull thickness. Hummel et al (2008) suggested that stimulation during or before intensive therapy yielded improved motor function or reaction time than when no therapy was given around the stimulation. Several other review articles and studies suggest using both high definition tDCS, which increases the focality of the current, and/or using neurotargeting software that uses the patient's own CT/MRI in the computation of the electrical montage can create a more personalized tDCS regimen.7,11,12 This study plans to do both. The Soterix MxN neuromodulation system has been used in multiple studies and has a targeting system that would help ensure both ideal current, more focal stimulation and optimal lead placements is essential as according to Datta et al (2011). Lesions within the brain may alter the flow of current through that area. The software system, HD-Targets, will be used that takes the patient's own MRI to account for variabilities in skull thickness, lesion size/location/composition, fluid density, and cerebrospinal fluid presence. These variabilities are used in the computer algorithm that simulates current flow through that specific participant's brain to get to the desired target area with the least amount of current and decreased stimulation of undesired areas. The investigators will examine these patients before and after treatment and compare the two groups, treatment group and sham group, after they receive 10 sessions of 20minutes along with their regular course of physical, occupational, or speech therapy over the course of their inpatient rehab stay.

Subjects will be given high definition transcranial direct current stimulation (tDCS) via a Soterix MxN HD-tDCS stimulator. This device is for investigational use only at this time and is not FDA approved. However, it has been used in several multicenter and randomized control trials that are detailed below in Appendix 1. The patient's MRi will be sent out to Soterix where they will manually input the variations in skull thickness, fluid density, lesion size, cerebrospinal fluid, and gray/white matter variabilities. They will then run the algorithm with HD-Targets, sophisticated current simulating software, to obtain optimal electrode placement to target the primary motor cortex (M1 area), the region of the brain that is responsible for movement, of each individual patient. Another issue with tDCs is maintaining optimal connections between the patient's scalp and the electrodes. Sotetrix HD-tDCs uses SmartScan™ to assure proper lead contact with initial set-up to adjust electrodes and head-gear for optimal fit. During stimulation, SmartScan™ provides a constant indication of electrode quality and can be monitored during adjustments to assure continuous lead contact.

Eligibility criteria: Inclusion Criteria:

1. Adults 18-90 years old
2. Diagnosed with middle cerebral artery ischemic stroke
3. Upper extremity movement deficits
4. Cardiorespiratory function is stable
5. Admitted to acute inpatient rehabilitation
6. Intact corticospinal tract

Exclusion Criteria:

1. Previous stroke
2. Pre-stoke weakness or disability in the paretic arm
3. Severe neglect
4. Acute exacerbation of heart failure or COPD
5. Severe aphasia
6. Decisional Impairment
7. Pregnant or nursing women
8. Prisoner
9. Skin disorder or wound of scalp
10. Seizure disorder

Primary outcomes:
measure: Change in the Fugl-Meyer upper extremity assessment
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Secondary outcomes:
measure: Change in the Wolf Motor Function Test
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Change in the Functional Independence Measure
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Change in the Action Research Arm Test
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Kinematic measurements with Kinereach system: measurement of change arm speed
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Kinematic measurements with Kinereach system: measurement of change in arm smoothness
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Kinematic measurements with Kinereach system: measurement of change in arm range of motion
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Change in National institute of Health Stroke Scale
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
measure: Change in Modified Rankin Scale
timeFrame: Assessments will be taken at baseline and after treatment (about 2 weeks) to determine change in the score after the treatments or sham stimulation has been given.
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: William A Pomilla, MD
role: PRINCIPAL_INVESTIGATOR
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