Brain Connectivity as a Biomarker of Response to Transcranial Stimulation by Continuous Current in Patients With Stroke
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
A randomized, double-blind, sham-controlled clinical trial will be conducted with 30 people with stroke, recruited at a referral hospital in João Pessoa. After recruitment they will be randomized into two groups: Group 1 - active stimulation and group - 2 sham stimulation. Participants will receive 10 sessions of ETCC, for 20 minutes, on alternate days (3 times a week), where the electrodes will be positioned over the primary motor cortex. 3 minutes of EEG at rest will be taken from each participant, and they will be instructed not to be actively involved in any cognitive or mental activity. In the first and last meetings, evaluations will be carried out, the outcomes evaluated will be: motor function, quality of life and functional connectivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started May 2022
Shorter than P25 for not_applicable stroke
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
First Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 9, 2022
May 1, 2022
4 months
February 10, 2021
May 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor function
For the analysis of the primary outcome, the fulgl-Meyer evaluation scale will be used. The scale consists of a cumulative numerical scoring system that assesses aspects related to range of motion, pain, sensitivity, motor function of the upper and lower extremities, in addition to coordination and speed.
Baseline and after 3 weeks
Secondary Outcomes (2)
Change in quality of life
Baseline and after 3 weeks
Functional Connectivity
Baseline and after 3 weeks
Study Arms (2)
active tDCS
EXPERIMENTALParticipants will receive 10 ETCC sessions, for 20 minutes, on alternate days (3 times a week). The electrodes will be positioned on the primary motor cortex (position C3 or C4 according to the international electroencephalogram system - EEG 10/20), with the anode positioned on the affected hemisphere and the cathode on the supraorbital region in the hemisphere contralateral to the injury. The electrodes will be wrapped with sponges of 5 x 7 cm and moistened with saline (NaCl 0.9%). The current intensity will be 2mA.
Sham tDCS
SHAM COMPARATORThe protocol for placebo stimulation will be identical, but the device will stop emitting current 30 seconds after the start of stimulation.
Interventions
Eligibility Criteria
You may qualify if:
- Have had a single episode of unilateral, ischemic stroke, in middle cerebral artery proven by means of magnetic resonance imaging or computed tomography;
- Young adult individuals, over 18 years old;
- Both sexes;
- Patients in late subacute stage. Late sub-acute stage will be considered for patients between 3 and 6 months after stroke;
- Mild to moderate patients with a Fugl-Meyer score \>85 points;
- Patients with mild to moderate degree of injury severity (NIHHS \<17 points);
- Presentation of up to 4 points on the Rankin scale.
You may not qualify if:
- Use of drugs that modulate the activity of the Central Nervous System;
- Carriers of implanted metallic or electronic devices; cardiac pacemaker;
- habitual use of drugs or alcohol;
- Epilepsy history report; gestation; people with traumatic brain injury or tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suellen Andrade
Federal University of Paraiba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will be divided into 02 groups: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants will be included in the study using the eligibility criteria and will be randomly allocated, in 1: 1 blocks, where a random number generator will be used through an online randomization program (www.random.org). All researchers responsible for the evaluation before and after consultations will be blind to the type of treatment that the patient will receive (active stimulation or sham stimulation). The effectiveness of the masking mechanism will be assessed at the time of the last interview with the patients, when they will be asked about their opinions as to whether the electric current producing system was on or off.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Researcher and Professor
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 12, 2021
Study Start
May 1, 2022
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05