NCT03826030

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

Conditions

• Stroke, Ischemic
• Motor Activity
• Upper Extremity Paralysis

Interventions

Type	Name	Description
DEVICE	Sham	Sham group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject.
DEVICE	Low dose tDCS	The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session
DEVICE	High dose tDCS	The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session
BEHAVIORAL	mCIMT	All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session

Timeline

• Start date: 2019-09-01
• Primary completion: 2024-09-19
• Completion: 2024-09-19
• First posted: 2019-02-01
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study