NCT02763826: COBRE_JIpro3

Optimizing Current and Electrode Montage for Transcranial Direct Current Stimulation in Stroke Patients

Completed NA Results posted Last updated 13 October 2021

What this trial tests

NA trial testing transcranial direct current stimulation in Stroke in 31 participants. Completed in 26 April 2019.

Timeline

8 December 2014

Primary endpoint
26 April 2019

26 April 2019

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	8 December 2014
Primary completion	26 April 2019
Estimated completion	26 April 2019
Sites	1 location across United States

Drugs / interventions tested

• transcranial direct current stimulation

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 80, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Major Response Primary · Immediately after intervention on the day of tDCS application

Major response is any of the following: * Second degree scalp burn at the site of electrode pad; or * Seizure; or * New lesion(s) on Diffusion Weighted Imaging (DWI) sequence of MRI scan and the lesion(s) not explained by any other cause(s) or decreased Apparent Diffusion Coefficient (ADC) under the electrode stimulating motor cortex area; * Discontinuation of subject from the study due to any of above. In a 3+3 design, 3 subjects are recruited for a given tDCS dose level. The trial is stopped if ≥2 of 3 subjects at a given tDCS dose level show major response. If only 1 of 3 subjects shows m

Group	Value	95% CI
1 mA Bihemispheric tDCS	0
2 mA Bihemispheric tDCS	0
2.5 mA Bihemispheric tDCS	0
3 mA Bihemispheric tDCS	0
3.5 mA Bihemispheric tDCS	0
4 mA Bihemispheric tDCS	0
4 mA Anodal tDCS	0
4 mA Cathodal tDCS	0

Sponsor's own description

The purpose of this study is to determine the optimal transcranial direct current stimulation (tDCS) amplitude and electrode montage that is both safe and efficacious

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study.
   Chhatbar PY, Chen R, Deardorff R, Dellenbach B, et al · · 2017 · cited 94× · PMID 28279641 · DOI 10.1016/j.brs.2017.02.007
2. 2017 Annual Meetings.
   · 2017 · cited 1× · PMID 29032633 · DOI 10.1002/ana.25024