NCT01828398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

April 5, 2013

Last Update Submit

January 15, 2014

Conditions

StrokeUpper Extremity Impairments

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Upper Extremity

    Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

    A week prior to treatment beginning

Secondary Outcomes (4)

  • Box and Block Test

    A week prior to treatment beginning

  • Ashworth Modified Scale

    A week prior to treatment beginning

  • Motor Activity Log (MAL)

    A week prior to treatment beginning

  • Assessment of cortical excitability (TMS)

    A week prior to treatment beginning

Study Arms (2)

sham-tDCS + UE robot-assisted therapy

SHAM COMPARATOR

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

real-tDCS + UE robot-assisted therapy

EXPERIMENTAL

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

Interventions

real-tDCS + UE robot-assisted therapyDEVICE
real-tDCS + UE robot-assisted therapy
sham-tDCS + UE robot-assisted therapyDEVICE
sham-tDCS + UE robot-assisted therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferrara University Hospital

Ferrara, Italy

Location

Related Publications (1)

  • 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.

    PMID: 33175411DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 10, 2013

Study Start

November 1, 2011

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

IT(1)