Priming With tDCS: Expanding the Window of Recovery in Chronic Stroke

NCT03964467 | Unknown FDA Device

• 1 other identifier: 06-0008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke often leads to long-term disability including upper extremity (UE) dysfunction even with the provision of timely rehabilitation services. Brain injury stemming from stroke, affecting the corticospinal system results in weakness, alterations in muscle tone and incoordination during the performance of functional tasks. Recovery of functional task performance after injury to the corticospinal system involves a residual neural network that engages the premotor cortex, frontal cortex and supplementary motor cortex. In particular, the dorsal premotor cortex (PMd) is anatomically and physiologically poised to reorganize and support motor recovery after corticospinal damage. The goal of this study is to determine the feasibility and efficacy of stimulating the ipsilesional PMd in adults with chronic stroke using noninvasive anodal transcranial direct current stimulation (tDCS) during the training sessions of a 4-week circuit-based, UE, task-related training (TRT) program. Pilot data from six adults, using anodal tDCS over the injured PMd just before each session of TRT, led to significant improvements in UE function in 5 of the 6 adults after only 4 weeks of training. We will assess the motor function of both arms using clinical assessments immediately before and after the 4-week TRT program. In addition to effects of tDCS-primed UE-TRT on clinical outcomes, we will use functional magnetic resonance imaging (fMRI) to determine the changes in neural network reorganization. We hypothesize that the training program will reveal significant improvement in motor function based on clinical assessment as well as significant global network changes based on resting state functional MRI and hybrid diffusion MR imaging. The long-term goal of this research is to develop an effective intervention strategy to improve UE function in individuals with moderate impairment from chronic stroke.

Conditions

Upper Extremity Paresis

Keywords

stroke; upper extremity; intervention; transcranial direct current stimulation; actigraph; fMRI

Outcome Measures

Primary Outcomes (4)

• UE Accelerometry

  actigraph markers placed on each arm

  3 day period prior to training

• UE Accelerometry

  actigraph markers placed on each arm

  3 day period post training to assess change- more activity inbdicates greater overall use

• Functional MRI

  fMRI consisting of structural data collected, DTI, resting state data functional task data

  within 3 days prior to training

• Functional MRI

  fMRI consisting of structural data collected, DTI, resting state data and functional task data

  within 3 days post training to measure change- increased activity in designated areas explains pattern of neuroplasticity

Secondary Outcomes (10)

• Body Structure Function and Impairment Data

  1-3 days prior to training start

• Body Structure Function and Impairment Data

  1-3 days post training

• Body Structure Function and Impairment Data

  1-3 days prior to training start

• Body Structure Function and Impairment Data

  1-3 days post training

• Body Structure Function and Impairment Data

  1-3 days prior to training start

Study Arms (2)

Experimental

EXPERIMENTAL

Transcranial Direct Current Stimulation.1) Scalp measurements of the scalp will be taken using the 10-20 EEG measurement system to determine anode and cathode placement. 2) One 1x1 Bicarbon electrode with wires attached will be placed in the center of each 5 cm x 7 cm sponge electrode dampened with 8 ml of saline. 3) One sponge electrode will be placed over the ipsilesional PMd (F3) and the other sponge electrode over the contralesional supraorbital region(Fp2). 4) Each sponge electrode will be secured under the plastic EZ strap 5) The current from the Actividose II will be turned up to 2 MA. The current will ramp up/down in 15 seconds. We will observe for adverse effects and hit the pause button, then turn the machine off, if a participant does not tolerate the stimulation. Individuals in this arm will have the stimulation stay in current until the full dose is delivered. Each participant will then engage in the UE TRT as outlined below.

Device: transcranial direct current stimulation

Control

SHAM COMPARATOR

Individuals in this arm will have the stimulation cycled off after 2-3 minutes. All will be part of the Circuit-Based, UE Task Related Training. Each participant will engage in the training program for 1.5 hours; rotating through 5 stations at about 15 minute intervals, participating in standing as tolerated, but stations can be adapted to sitting. The goal is for each participant perform \> 225 movements with the affected arm per session, at the highest functional level. Rest breaks given as needed. Examples of stations are: Reach-to-grasp tasks to objects of various weight, texture and dimension at different distances and table heights. Practice opening simulated locks and containers. Shoulder wheel involving grasping plastic plates with varied grip patterns and sliding them up and over the wheel from the unaffected to the affected side encouraging shoulder abduction, external rotation and supination. Bimanual/unimanual ball toss: catching, releasing.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

see arm/group descriptions

Also known as: Upper extremity Circuit training

Control; Experimental

Eligibility Criteria

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

You may qualify if:

• \> 18-75 years of age;
• diagnosis of ≥ 1 stroke \> 6 months before participation;
• in good health;
• classified with moderate impairment based on the UE Fugl Meyer Assessment (FMA; score of 19-47
• safe for the MRI environment;
• able to elevate and hold the paretic arm for 2 seconds at 90 degs shoulder elevation, 160-180O elbow extension and neutral forearm supination;
• ≥ 20 degrees gravity minimized wrist extension while holding a cylindrical object on a tabletop.

You may not qualify if:

• bone or joint limitations that restrict paretic arm motion;
• history of skull fractures or burr hole(s);
• resting heart rate and resting blood pressure outside the range of 40-100 beats/min and 90/60 to 170/90 mm Hg respectively;
• chest pain or shortness of breath at rest;
• history epilepsy or seizures;
• Botox injections to the paretic arm within 4 months of participation.

Sponsors & Collaborators

• University of the Sciences in Philadelphia: lead
• Chapman University: collaborator
• Moss Rehabilitation Research Institute: collaborator
• Thomas Jefferson University: collaborator

Study Sites (1)

University of the Sciences

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Paresis; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Gregory Thielman, EdD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PI is only doing the testing, while the trainers are training all the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Therapy and Neuroscience

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 28, 2019
• Study Start: January 14, 2019
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: as requested and up to 5 years

Locations

US (1)