Robots Paired With tDCS in Stroke Recovery

Northwell Health

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Device: Placebo sham; Device: Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01726673

12-102B

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

tDCS + robotic arm therapy

Experimental group

Description:

Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Treatment:

Device: Transcranial Direct Current Stimulation (tDCS)

tDCS sham + robotic arm therapy

Placebo Comparator group

Description:

Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)

Treatment:

Device: Placebo sham