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Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital of Ferrara
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT01883843
First received: June 14, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.

Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.

Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.

Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.

The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.


Condition Intervention Phase
Chronic Stroke
Device: sham tDCS + TOCT
Device: real tDCS + TOCT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial

Further study details as provided by University Hospital of Ferrara:

Primary Outcome Measures:
  • Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 10 meter walking test (test of 10m) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up ] [ Designated as safety issue: No ]
    walking speed test

  • Timed "up and go" test (TUG) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]
  • Unified Balance Scale (UBS) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale (FSS) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]
  • Stroke Impact Scale (SIS) version 3.0 [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]
  • Stroke Specific Quality of Life (SS-QOL) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: real tDCS + TOCT

Every day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode.

The current reaches 0.5mA and decreases with a ramp of 10 seconds.

Device: real tDCS + TOCT
Active Comparator: sham-tDCS + TOCT
Every day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group.
Device: sham tDCS + TOCT

Detailed Description:

Inclusion criteria:

  • Males and females subjects. Age > 18 years, <75 years.
  • Diagnosis of first ischemic stroke > 6 months.
  • Mini mental State Examination (MMSE) >24;
  • Functional Ambulation Classification (FAC) higher or equal to 4
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Males and females subjects. Age > 18 years, <75 years.
  • Diagnosis of first ischemic stroke > 6 months.
  • MMSE>24;
  • FAC higher or equal to 4

Exclusion Criteria:

  • Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants).
  • Neurological or psychiatric pathology.
  • Severe cardio-pulmonary, renal, hepatic diseases.
  • Pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883843

Contacts
Contact: Carlotta Martinuzzi, PT 0039 0532 238720 costes@alice.it

Locations
Italy
Ferrara University Hospital Recruiting
Ferrara, Italy, 44124
Contact: Carlotta Martinuzzi, PT    0039 0532 8720    costes@alice.it   
Sub-Investigator: Claudia Pavarelli, PT         
Sub-Investigator: Andrea Baroni, PT         
Sub-Investigator: Filippo Ferro, mister         
Sub-Investigator: Amira Charabati, PT         
Sponsors and Collaborators
University Hospital of Ferrara
  More Information

No publications provided

Responsible Party: Sofia Straudi, MD, Physical Medicine and Rehabilitation doctor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01883843     History of Changes
Other Study ID Numbers: Stroke_tDCS_TOCT
Study First Received: June 14, 2013
Last Updated: January 15, 2014
Health Authority: Italy: Ferrara Ethics Committee

Keywords provided by University Hospital of Ferrara:
Chronic Stroke
tDCS
transcranial direct current stimulation
task oriented circuit training
TOCT
gait training

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014