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Behavioural Intervention

Experimental for Weakness of the Upper Extremity

N/A
Waitlist Available
Led By Gregory Thielman, EdD
Research Sponsored by University of the Sciences in Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-3 days post training
Awards & highlights

Study Summary

This trialwill assess the effects of stimulating a specific area of the brain with electricity during physical therapy for stroke patients, to help improve upper extremity function.

Eligible Conditions
  • Weakness of the Upper Extremity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-3 days post training
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 days post training for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional MRI
UE Accelerometry
Secondary outcome measures
Body Structure Function and Impairment Data

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
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.
Group II: ControlPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial direct current stimulation
2013
Completed Phase 3
~1430

Find a Location

Who is running the clinical trial?

Chapman UniversityOTHER
6 Previous Clinical Trials
1,367 Total Patients Enrolled
Moss Rehabilitation Research InstituteOTHER
10 Previous Clinical Trials
9,890 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
445 Previous Clinical Trials
145,475 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Priming With tDCS: Expanding the Window of Recovery in Chronic Stroke
Gregory Thielman 2019. "Priming With tDCS: Expanding the Window of Recovery in Chronic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03964467.
~2 spots leftby Apr 2025
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