NCT02156635

Brief Summary

The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 26, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

May 26, 2014

Last Update Submit

December 4, 2015

Conditions

StrokeCerebrovascular DisordersCerebral Infarction

Keywords

RehabilitationDirect Current StimulationAcute Stroke

Outcome Measures

Primary Outcomes (1)

  • Functional Independence measured by Barthel Index

    Change for functional independence at 4 months

Secondary Outcomes (11)

  • Cognitive dysfunction (Montreal Cognitive Assessment)

    Baseline (week 1) and Endpoint (week 4)

  • Executive functions (Victoria version of the Stroop Color and Word Test)

    Baseline (week 1) and Endpoint (week 4)

  • Attention and Working Memory (Digit span subtest)

    Baseline (week 1) and Endpoint (week 4)

  • Spasticity

    Baseline, Week 2 and Week 4

  • Muscle strength

    Baseline, Week 2 and Week 4

  • +6 more secondary outcomes

Study Arms (2)

Active tdcs / CIMT

EXPERIMENTAL

Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT)

Device: Transcranial direct current stimulationBehavioral: Constraint-Induced Movement Therapy

Sham stimulation / CIMT

SHAM COMPARATOR

Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT)

Behavioral: Constraint-Induced Movement TherapyOther: Placebo

Interventions

Transcranial direct current stimulationDEVICE
Active tdcs / CIMT
Constraint-Induced Movement TherapyBEHAVIORAL
Active tdcs / CIMTSham stimulation / CIMT
PlaceboOTHER
Sham stimulation / CIMT

Eligibility Criteria

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

You may qualify if:

  • Ischaemic acute stroke
  • Informed consent

You may not qualify if:

  • ≤ National Institute of Health Stroke Scale ≤ 32
  • Rankim ≥ 5
  • Mini Mental State Examination ≤ 24
  • tDCS criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system CIMT criteria: inability to actively execute the movements of wrist flexion, metacarpophalangeal and interphalangeal active extension of 10º and wrist extension of 20º

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, 58051-900, Brazil

Location

Related Publications (2)

  • 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

  • Andrade SM, Santos NA, Fernandez-Calvo B, Boggio PS, Oliveira EA, Ferreira JJ, Sobreira A, Morgan F, Medeiros G, Cavalcanti GS, Gadelha ID, Duarte J, Marrocos J, Silva MA, Rufino T, Nobrega SR. Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial. Trials. 2016 Jan 28;17:56. doi: 10.1186/s13063-016-1186-7.

    PMID: 26822418DERIVED

MeSH Terms

Conditions

StrokeCerebrovascular DisordersCerebral Infarction

Interventions

Transcranial Direct Current StimulationConstraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesExercise TherapyPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Suellen Andrade

CONTACT

suellenandrade@gmail.com

Study Design

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

Study Record Dates

First Submitted

May 26, 2014

First Posted

June 5, 2014

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

December 7, 2015

Record last verified: 2015-12

Locations

BR(1)