HD-tDCs to Improve Upper Extremity Function in Patients With Acute Middle Cerebral Artery Stroke

March 15, 2022 updated by: Milton S. Hershey Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
Treatment with 'Soterix MxN Neuromodulation device (high definition transcranial direct current stimulator) using HD-Targets for optimal neural targeting will be provided to participants and will include 20 minutes of stimulation coupled with conventional OT treatment during and after the intervention. There will be a total of 10 sessions over about a 2 week period.
Device: Soterix MxN Neuromodulation device
Up to 2 mA stimulation to primary motor cortex for 10 sessions at 20min per session
SHAM_COMPARATOR: Sham group
Sham stimulation will consist of using the devices auto-sham feature. The exact same setup/device will be used during both groups. This is considered a control for the experiment. Both groups will receive similar physical occupational and speech therapy
Device: Sham Stimulation
Uses slight stimulation initially then turns of and provides no stimulation after a few seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Fugl-Meyer upper extremity assessment
Time Frame: 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.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It measures performances on motor function of the upper extremity. Range is from 0-66 with 66 being totally normal in all assessments. Each Sub score for each category ranges from 0-2 with 0 being not able to finish and 2 meaning function is normal in this category.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Wolf Motor Function Test
Time Frame: 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.
Quantifies upper extremity (UE) motor ability through timed and functional tasks. Thus, it measures how well a task can be performed by the subject, and the patient is given a score from 0-6. Zero being did not perform, and six being normal. The changes in performance can be compared over time to assess their progress. Each task is subscaled from 0-6 with 6 being indepednetly performed and 0 being unable to perform or needs to be performed by someone else for the patient.
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.
Change in the Functional Independence Measure
Time Frame: 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.
A uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps for use in the medical system in the United States. It is a measure of a person's physical, psychological, and social functions to assess their level of disability. It is a scale from 18-126 with a score of 126 being completely normal or independent in all of the tasks. 17 tasks in total: 6 are functional tasks, 2 measure strength, and 9 analyze movement quality or efficiency. Each task is subscored from 1-7 with 7 being completely independent completing a task and 1 meaning the person is fully dependent on someone completing that task for them.
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.
Change in the Action Research Arm Test
Time Frame: 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.
Evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). This measures 19 items covering four domains of upper extremity movement: grasp, grip, pinch, and gross motor. Score ranges from 0-57 with 57 being normal function in all domains. Each task has a subscore of 0-3 with 0 being unable to perform movement and 3 being normal function.
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.
Kinematic measurements with Kinereach system: measurement of change arm speed
Time Frame: 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.
Developed by Robert Sainburg. The machine is able to measure how fast a patient's arm is able to move through space. Speed would be quantified as the peak and/or average tangential velocity of the hand during self-paced reaching movements.
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.
Kinematic measurements with Kinereach system: measurement of change in arm smoothness
Time Frame: 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.
Developed by Robert Sainburg. The machine is able to measure how smooth a patient is able to move their arm through space. Smoothness is measured as mean squared Jerk: This is quantified as the third derivative of displacement (jerk) squared and averaged over time.
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.
Kinematic measurements with Kinereach system: measurement of change in arm range of motion
Time Frame: 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.
Developed by Robert Sainburg. The machine is able to measure range of motion that would be quantified as the largest 2D area encircled by the hand, when asked to make the biggest circle possible. .
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.
Change in National institute of Health Stroke Scale
Time Frame: 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.
15-item impairment scale, intended to evaluate neurologic outcome and degree of recovery for patients with stroke. Range of scores from 0-42 with zero being no symptoms and 42 being severely impaired. It is a way to quantify stroke severity with measures for the typical stroke symptoms including level on consciousness, language, vision, motor and sensory involvement, as well as some cognitive assessments.
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.
Change in Modified Rankin Scale
Time Frame: 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.
Single item, global outcomes rating scale for patients post-stroke. Range is from 0-6. Zero being no symptoms and 6 being dead. In-between measures consist of how much help they require during their activities of daily living.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: William A Pomilla, MD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 5, 2020

Primary Completion (ANTICIPATED)

September 5, 2022

Study Completion (ANTICIPATED)

September 5, 2022

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (ACTUAL)

June 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • None at this time

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No identifying data will be distributed. Demographic information with used within the groups to assess treatment versus sham homogenicity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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