Phase 2
Completed N=54
Robots Paired With tDCS in Stroke Recovery
Source: ClinicalTrials.gov NCT01726673 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Median Change in Upper Extremity Fugl Meyer Assessment Score — 4.5; 6.0; 4; 6 scores on a scale — p=0.256
Summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change in Upper Extremity Fugl Meyer Assessment Score |
4.5; 6.0; 4; 6 | 0.256 |
| SECONDARY Median Change in WOLF Motor Function Test (WMFT) |
-34; -19; -103; -81.5 | 1.0 |
| SECONDARY Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC) |
7; 7; 6; 6 | 0.680 |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- Cognitive function sufficient enough to understand experiments and follow instructions
- Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion Criteria
- Botox treatment within 6 weeks of enrollment
- Fixed contraction of the affected limb
- Complete flaccid paralysis of the affected limb
- History of hemorrhagic stroke
- Ongoing use of CNS active medications
- Ongoing use of psychoactive medications
- Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures
Data sourced from ClinicalTrials.gov (NCT01726673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.