NCT02628561

Brief Summary

The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

December 4, 2015

Last Update Submit

April 3, 2016

Conditions

StrokeCerebrovascular DisordersCerebral Infarction

Outcome Measures

Primary Outcomes (1)

  • Functional Independence measured by Barthel Index

    Change for functional independence at baseline and week 2

Secondary Outcomes (2)

  • Spasticity (Modified Ashworth Scale)

    Baseline and Week 2

  • Muscle strength (Medical Research Council Scale)

    Baseline and Week 2

Study Arms (3)

Active tdcs/M1

ACTIVE COMPARATOR

Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)

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

Active tdcs/Premotor

EXPERIMENTAL

Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)

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

Sham tdcs

SHAM COMPARATOR

Sham tDCS and CIMT (constraint induced movement therapy)

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

Interventions

Transcranial direct current stimulationDEVICE
Active tdcs/M1Active tdcs/PremotorSham tdcs
Constraint-Induced Movement TherapyBEHAVIORAL
Active tdcs/M1Active tdcs/PremotorSham tdcs

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years
  • Diagnosis of unilateral, non-recurring, subacute stroke
  • Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.

You may not qualify if:

  • Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suellen Andrade

João Pessoa, Paraíba, Brazil

Location

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

Study Design

Study Type
interventional
Phase
phase 1
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
PhD

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 11, 2015

Study Start

January 1, 2016

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

April 5, 2016

Record last verified: 2016-04

Locations

BR(1)