Adults 18 to 80, any sex, with Stroke, Ischemic or Motor Activity. 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.
Mean Change in FM-UE From BaselinePrimary· Day 15
The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were
Group
Value
95% CI
Sham tDCS + mCIMT
4.91
3.00 – 6.82
2 mA tDCS + mCIMT
3.87
2.00 – 5.74
4 mA + mCIMT
5.53
3.64 – 7.42
Mean Change in WMFT Time Score From BaselineSecondary· Day 15
The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better.
Group
Value
95% CI
Sham tDCS + mCIMT
-8.67
-15.50 – -1.84
2 mA tDCS + mCIMT
-1.65
-8.76 – 5.46
4 mA + mCIMT
-10.37
-18.64 – -2.11
Mean Change in SIS Hand Subscale From BaselineSecondary· Day 15
The Stroke Impact Scale (SIS) has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). The domain/subscale scores, including the SIS Hand Subscale, range from 0 (worst) to 100 (best).
Group
Value
95% CI
Sham tDCS + mCIMT
25.24
19.13 – 31.36
2 mA tDCS + mCIMT
13.60
8.01 – 19.20
4 mA + mCIMT
21.51
15.77 – 27.25
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 105 days after randomization.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 22 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03826030.