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tDCS and Robotic Therapy in Stroke

Primary Purpose

Stroke, Upper Extremity Impairments

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
real-tDCS + UE robot-assisted therapy
sham-tDCS + UE robot-assisted therapy
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ferrara University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

sham-tDCS + UE robot-assisted therapy

real-tDCS + UE robot-assisted therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary Outcome Measures

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.
Ashworth Modified Scale
a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
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.
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

Full Information

First Posted
April 5, 2013
Last Updated
January 15, 2014
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT01828398
Brief Title
tDCS and Robotic Therapy in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Impairments

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham-tDCS + UE robot-assisted therapy
Arm Type
Sham Comparator
Arm 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.
Arm Title
real-tDCS + UE robot-assisted therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
real-tDCS + UE robot-assisted therapy
Intervention Type
Device
Intervention Name(s)
sham-tDCS + UE robot-assisted therapy
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity
Description
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Time Frame
A week prior to treatment beginning
Secondary Outcome Measure Information:
Title
Box and Block Test
Description
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.
Time Frame
A week prior to treatment beginning
Title
Ashworth Modified Scale
Description
a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
Time Frame
A week prior to treatment beginning
Title
Motor Activity Log (MAL)
Description
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.
Time Frame
A week prior to treatment beginning
Title
Assessment of cortical excitability (TMS)
Description
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
Time Frame
A week prior to treatment beginning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

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tDCS and Robotic Therapy in Stroke

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