StrokePhase 2/3NeuroCogNCT02315807
Neurostimulation for Cognitive Rehabilitation in Stroke
A Phase 2/3 study testing transcranial direct current stimulation in people with Stroke and Cognitive Impairment, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stroke, Cognitive Impairment, Cerebral Infarction
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ischaemic chronic stroke
- Mild/Moderate Cognitive impairment
- Informed consent
Who cannot join
- National Institute of Health Stroke Scale (NIHSS) ≥ 16 points
- Severe cognitive comorbidities (dementia, depression)
- transcranial direct current stimulation 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
Trial locations and contacts
1 site in 1 country.
Suellen Andrade contact
Brazil1 site, 1 recruiting
- Recruiting
Suellen Andrade
João Pessoa, Paraíba
Suellen Andrade
About this study
Official title: Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)
Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Sixty patients who suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.
- Conditions
- Stroke, Cognitive Impairment, Cerebral Infarction
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Stroke, Cognitive Dysfunction, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tdcs
| Study group | Role | What they receive |
|---|---|---|
| dlPFC | Experimental | Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex Receives: Device: transcranial direct current stimulation |
| CON | Experimental | Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network Receives: Device: transcranial direct current stimulation |
| M1 | Active comparator | Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function measured by Dysexecutive Questionnaire (DEX)
Measured: Change for executive functions at 4 weeks
Secondary outcomes (5)
Verbal Fluency (Semantic Fluency Test)
Measured: [ Time Frame: Baseline, Week 2 and Week 4 ]
Response inhibition (Go-no-go Test)
Measured: [ Time Frame: Baseline, Week 2 and Week 4 ]
Executive function (Wechsler Intelligence Scale for Adults)
Measured: [ Time Frame: Baseline, Week 2 and Week 4 ]
Memory (Rey Auditory Verbal Learning)
Measured: [ Time Frame: Baseline, Week 2 and Week 4 ]
Processing Speed (Letter Comparison and Pattern Comparison Tasks)
Measured: [ Time Frame: Baseline, Week 2 and Week 4 ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2015
- Primary completionMar 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, PhD, Principal investigator, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315807
- Sponsor's protocol ID
- NeuroCog001
- Acronym
- NeuroCog
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2014
- Last updated
- 7 Dec 2015
- Results posted
- No
Publications
Andrade SM, Fernandez-Calvo B, Boggio PS, de Oliveira EA, Gomes LF, Pinheiro Junior JE, Rodrigues RM, de Almeida NL, Moreira GM, Alves NT. Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial. Trials. 2015 Sep 29;16:435. doi: 10.1186/s13063-015-0945-1.
PubMed 26420269
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)
- ClinicalTrials.gov ID
- NCT02315807
- Acronym / sponsor ID
- NeuroCog / NeuroCog001
- Conditions
- Stroke, Cognitive Impairment, Cerebral Infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Sixty patients who suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dlPFC | Experimental | Device: transcranial direct current stimulationParticipants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex |
| CON | Experimental | Device: transcranial direct current stimulationParticipants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network |
| M1 | Active comparator | Device: transcranial direct current stimulationParticipants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ischaemic chronic stroke
- Mild/Moderate Cognitive impairment
- Informed consent
Key exclusion criteria (3 listed)
- National Institute of Health Stroke Scale (NIHSS) ≥ 16 points
- Severe cognitive comorbidities (dementia, depression)
- transcranial direct current stimulation 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationAlso: tdcs | Device | CON, M1, dlPFC |
Primary outcome
Executive Function measured by Dysexecutive Questionnaire (DEX)
Time frame: Change for executive functions at 4 weeks
5 secondary outcomes
Verbal Fluency (Semantic Fluency Test)
Time frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
Response inhibition (Go-no-go Test)
Time frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
Executive function (Wechsler Intelligence Scale for Adults)
Time frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
Memory (Rey Auditory Verbal Learning)
Time frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
Processing Speed (Letter Comparison and Pattern Comparison Tasks)
Time frame: [ Time Frame: Baseline, Week 2 and Week 4 ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Derived from this study: PubMed 26420269Andrade SM, Fernandez-Calvo B, Boggio PS, de Oliveira EA, Gomes LF, Pinheiro Junior JE, Rodrigues RM, de Almeida NL, Moreira GM, Alves NT. Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial. Trials. 2015 Sep 29;16:435. doi: 10.1186/s13063-015-0945-1.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suellen Andrade contact
Suellen Andrade, PhD principal investigator
Federal University of Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing transcranial direct current stimulation in people with Stroke and Cognitive Impairment, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade (suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function measured by Dysexecutive Questionnaire (DEX) (time frame: Change for executive functions at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.