Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

Auxilium Vitae Volterra

Status: Completed

Conditions: Stroke

Treatments: Device: Sham tDCS plus wrist robot therapy; Device: tDCS plus wrist robot therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02496026

RN20141

Details and patient eligibility

About

The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.

Full description

As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern.

As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.

Enrollment: 20 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. persons affected by first supratentorial stroke, whose onset time is 25±7 days;
2. upper limb hemiparesis;
3. cognitive and speech abilities sufficient to understand instructions and to provide informed consent;
4. absence of intense pain due to passive wrist mobilization assessed by VAS < 3 (range 0-10);
5. ability to provide written informed consent.

Exclusion criteria

1. previous epilepsy seizures;
2. severe electroencephalographic anomalies;
3. previous neurosurgery interventions involving metallic elements placement;
4. ongoing anticonvulsant drugs treatment
5. inability to keep sitting posture;
6. severe sensory deficits;
7. general clinical complication preventing delivery of rehabilitation treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

tDCS plus wrist robot therapy

Experimental group

Description:

In addition to standard rehabilitation treatment Group A will perform daily sessions of wrist robot-assisted treatment in combination with tDCS (30 minutes). During first 20 min of each session the patient receives a direct current stimulation through surface sponge electrodes (35 cm2), 2 milliampere intensity: the anodal electrode is placed on presumed lesional area, the cathodal electrode is placed on the controlateral orbital bone.

Treatment:

Device: tDCS plus wrist robot therapy

Sham tDCS plus wrist robot therapy

Sham Comparator group

Description:

Group B is treated as Group A, but tDCS, even if the cap is applied on the patient head, is not activated and no current is delivered.

Treatment:

Device: Sham tDCS plus wrist robot therapy