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

NCT04000269 | Withdrawn

• 1 other identifier: None at this time
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Middle Cerebral Artery Stroke

Outcome Measures

Primary Outcomes (1)

• Change in the Fugl-Meyer upper extremity assessment

  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 Outcomes (8)

• Change in the Wolf Motor Function Test

  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

  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

  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

  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

  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.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

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

Interventions

Soterix MxN Neuromodulation device DEVICE

Up to 2 mA stimulation to primary motor cortex for 10 sessions at 20min per session

Treatment Group

Sham Stimulation DEVICE

Uses slight stimulation initially then turns of and provides no stimulation after a few seconds.

Sham group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-90 years old
• Diagnosed with middle cerebral artery ischemic stroke
• Upper extremity movement deficits
• Cardiorespiratory function is stable
• Admitted to acute inpatient rehabilitation
• Intact corticospinal tract

You may not qualify if:

• Previous stroke
• Pre-stoke weakness or disability in the paretic arm
• Severe neglect
• Acute exacerbation of heart failure or COPD
• Severe aphasia
• Decisional Impairment
• Pregnant or nursing women
• Prisoner
• Skin disorder or wound of scalp
• Seizure disorder

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Related Publications (22)

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MeSH Terms

Conditions

Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• William A Pomilla, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot prospective double blinded randomized controlled trial

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: June 27, 2019
• Study Start: July 5, 2020
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share