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tDCS and Robotic Therapy in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828398
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Upper Extremity Impairments Device: real-tDCS + UE robot-assisted therapy Device: sham-tDCS + UE robot-assisted therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Sham Comparator: sham-tDCS + UE robot-assisted therapy
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.
Device: sham-tDCS + UE robot-assisted therapy
Experimental: real-tDCS + UE robot-assisted therapy

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.

Device: real-tDCS + UE robot-assisted therapy



Primary Outcome Measures :
  1. Fugl-Meyer Upper Extremity [ Time Frame: A week prior to treatment beginning ]
    Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.


Secondary Outcome Measures :
  1. Box and Block Test [ Time Frame: A week prior to treatment beginning ]
    Test for gross motor function. It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 minute.

  2. Ashworth Modified Scale [ Time Frame: A week prior to treatment beginning ]
    a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist

  3. Motor Activity Log (MAL) [ Time Frame: A week prior to treatment beginning ]
    Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.

  4. Assessment of cortical excitability (TMS) [ Time Frame: A week prior to treatment beginning ]

    MEP of upper limb muscles (first dorsal interosseous) will be recorded with surface EMG electrodes. neurophysiological parameters analyzed:

    • motor threshold at rest
    • MEP recruitment curve at rest
    • MEP amplitude



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females subjects. Age > 18 years.
  • Diagnosis of first ischemic stroke
  • Impairment of the upper limb
  • Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.

Exclusion Criteria:

  • anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
  • Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
  • contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
  • Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
  • Neurological or psychiatric pathology
  • severe cardio-pulmonary, renal, hepatic diseases
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828398


Locations
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Italy
Ferrara University Hospital
Ferrara, Italy
Sponsors and Collaborators
University Hospital of Ferrara
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Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01828398    
Other Study ID Numbers: Stroke_tDCS
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases