Robots Paired With tDCS in Stroke Recovery

Stroke Clinical Trial

Official title:

Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726673
• Other study ID #: 12-102B
• Status: Completed
• Phase: Phase 2
• Start date: September 2012
• Est. completion date: June 2018

Study information

• Verified date: May 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)

• Placebo sham

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci. 2009;27(3):199-207. doi: 10.3233/RNN-2009-0470. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Change in Upper Extremity Fugl Meyer Assessment Score	The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.	baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Secondary	Median Change in WOLF Motor Function Test (WMFT)	The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.	baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Secondary	Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)	The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.	12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)