NCT02542982

Brief Summary

This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_3 stroke

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

March 21, 2015

Last Update Submit

September 3, 2015

Conditions

Stroke

Keywords

tDCSmotor recovery

Outcome Measures

Primary Outcomes (1)

  • Jebsen Taylor Test of Hand Function

    changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately

    one day, two weeks and one month

Secondary Outcomes (2)

  • hand grip force

    two weeks and one month

  • upper limb Fugl-Meyer assessment of Motor Recovery after Stroke

    one day, two weeks and one month

Study Arms (2)

Active treatment

EXPERIMENTAL

Group of patients on active treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by 20 minutes of 2 mA anodal tDCS over the ipsilesional motor cortex.

Device: tDCS (Endomed 482; Enraf-Nonius B.V.)

Sham comparator

SHAM COMPARATOR

Group of patients on sham treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by sham tDCS over the ipsilesional motor cortex.

Device: tDCS (Endomed 482; Enraf-Nonius B.V.)

Interventions

tDCS (Endomed 482; Enraf-Nonius B.V.)DEVICE

non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered

Active treatmentSham comparator

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans
  • stroke duration \> 12 months
  • severe hand deficit at stroke onset (Medical Research Council grade \<2) and
  • subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts),
  • spasticity between 0-2 assessed on the Modified Ashworth Scale

You may not qualify if:

  • any clinically significant or unstable medical disorder,
  • diagnosis od major depression,
  • diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination \< 24).
  • any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Neurology, Military Medical Academy, Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Tihomir V Ilic, MD, PhD

    Military Medical Academy, Serbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2015

First Posted

September 7, 2015

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

SE(1)