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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tDCS plus wrist robot therapy

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.

Group Type EXPERIMENTAL

tDCS plus wrist robot therapy

Intervention Type DEVICE

Patients receive robotic rehabilitation session while tDCS stimulator is switched on

Sham tDCS plus wrist robot therapy

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.

Group Type SHAM_COMPARATOR

Sham tDCS plus wrist robot therapy

Intervention Type DEVICE

Patients receive robotic rehabilitation session while tDCS stimulator is switched off.

Interventions

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tDCS plus wrist robot therapy

Patients receive robotic rehabilitation session while tDCS stimulator is switched on

Intervention Type DEVICE

Sham tDCS plus wrist robot therapy

Patients receive robotic rehabilitation session while tDCS stimulator is switched off.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No