tDCS and Robotic Therapy in Stroke

Completed

Phase 2 Results N/A

Trial Description

After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.

Conditions

Interventions

  • Real-tDCS + UE robot-assisted therapy Device
    ARM 1: Kind: Experimental
    Label: real-tDCS + UE robot-assisted therapy
    Description: This group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes. Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA.
  • Sham-tDCS + UE robot-assisted therapy Device
    ARM 1: Kind: Experimental
    Label: sham-tDCS + UE robot-assisted therapy
    Description: This group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS. This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement. This method of sham stimulation was previously validated.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity A week prior to treatment beginning No
Secondary Box and Block Test A week prior to treatment beginning No
Secondary Ashworth Modified Scale A week prior to treatment beginning No
Secondary Motor Activity Log (MAL) A week prior to treatment beginning No
Secondary Assessment of cortical excitability (TMS) A week prior to treatment beginning No

Sponsors