tDCS and Robotic Therapy in Stroke

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828398
• Other study ID #: Stroke_tDCS
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2013
• Last updated: January 15, 2014
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee Ferrara
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke
• Upper Extremity Impairments

Intervention

Device:
• real-tDCS + UE robot-assisted therapy

• sham-tDCS + UE robot-assisted therapy

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Extremity	Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.	A week prior to treatment beginning	No
Secondary	Box and Block Test	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.	A week prior to treatment beginning	No
Secondary	Ashworth Modified Scale	a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist	A week prior to treatment beginning	No
Secondary	Motor Activity Log (MAL)	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.	A week prior to treatment beginning	No
Secondary	Assessment of cortical excitability (TMS)	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	A week prior to treatment beginning	No