Traumatic Brain InjuryPhase 2TMS/DAINCT02167971
Brain Stimulation for Traumatic Brain Injury
A Phase 2 study testing Active Coil in people with Traumatic Brain Injury and Diffuse Axonal Injury, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Diffuse Axonal Injury
- What is being tested?
- Active Coil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Aug 2017
- Phase
- Phase 2
- 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
- Clinical and radiological diagnosis of traumatic brain injury.
- Between one to two years after traumatic brain injuri
- Must be able to sign the Informed Consent Form
Who cannot join
- Drug addiction
- Uncontrolled epilepsy
- Extensive Cranial vault defects
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital - University of Sao Paulo Medical School
São Paulo, São Paulo, 054010-000
About this study
Official title: Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.
The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).
- Conditions
- Traumatic Brain Injury, Diffuse Axonal Injury
- Being tested
- Active Coil, Sham
- Keywords
- traumatic brain injury, diffuse axonal injury, repetitive transcranial magnetic stimulation, neuromodulation, cognitive rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Diffuse Axonal Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CoilOther
The patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains.
ShamOther
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
| Study group | Role | What they receive |
|---|---|---|
| Active Coil | Experimental | The patients assigned to this group will undergo repetitive Transcranial Magnetic Stimulation over 10 sessions (each one with 2,000 pulses) on left dorsolateral prefrontal cortex. Receives: Other: Active Coil |
| Sham | Sham comparator | The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
Measured: One week and three months after rTMS.
Secondary outcomes (3)
Evidence of improvement on Executive Function processes measured by cognitive evaluation.
Measured: one week and 3 months.
Evidence of improvement on Motor Coordination measured by cognitive evaluation.
Measured: one week and three months.
Changes in cortical excitability measured by single and paired-pulse TMS
Measured: one week and three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iuri Santana Neville Ribeiro, University of Sao Paulo
- Investigators
- Wellingson S Paiva, MD, Study chair, University of Sao PauloIuri N Ribeiro, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167971
- Sponsor's protocol ID
- USP-01
- Acronym
- TMS/DAI
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2014
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodrigues PA, Zaninotto AL, Ventresca HM, Neville IS, Hayashi CY, Brunoni AR, de Paula Guirado VM, Teixeira MJ, Paiva WS. The Effects of Repetitive Transcranial Magnetic Stimulation on Anxiety in Patients With Moderate to Severe Traumatic Brain Injury: A Post-hoc Analysis of a Randomized Clinical Trial. Front Neurol. 2020 Dec 4;11:564940. doi: 10.3389/fneur.2020.564940. eCollection 2020.
PubMed 33343483Neville IS, Zaninotto AL, Hayashi CY, Rodrigues PA, Galhardoni R, Ciampi de Andrade D, Brunoni AR, Amorim RLO, Teixeira MJ, Paiva WS. Repetitive TMS does not improve cognition in patients with TBI: A randomized double-blind trial. Neurology. 2019 Jul 9;93(2):e190-e199. doi: 10.1212/WNL.0000000000007748. Epub 2019 Jun 7.
PubMed 31175209Neville IS, Hayashi CY, El Hajj SA, Zaninotto AL, Sabino JP, Sousa LM Jr, Nagumo MM, Brunoni AR, Shieh BD, Amorim RL, Teixeira MJ, Paiva WS. Repetitive Transcranial Magnetic Stimulation (rTMS) for the cognitive rehabilitation of traumatic brain injury (TBI) victims: study protocol for a randomized controlled trial. Trials. 2015 Oct 5;16:440. doi: 10.1186/s13063-015-0944-2.
PubMed 26438108
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.
- ClinicalTrials.gov ID
- NCT02167971
- Acronym / sponsor ID
- TMS/DAI / USP-01
- Conditions
- Traumatic Brain Injury, Diffuse Axonal Injury
- Keywords
- traumatic brain injury, diffuse axonal injury, repetitive transcranial magnetic stimulation, neuromodulation, cognitive rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Jun 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.
The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Coil | Experimental | Other: Active CoilThe patients assigned to this group will undergo repetitive Transcranial Magnetic Stimulation over 10 sessions (each one with 2,000 pulses) on left dorsolateral prefrontal cortex. |
| Sham | Sham comparator | Other: ShamThe patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical and radiological diagnosis of traumatic brain injury.
- Between one to two years after traumatic brain injuri
- Must be able to sign the Informed Consent Form
Key exclusion criteria (3 listed)
- Drug addiction
- Uncontrolled epilepsy
- Extensive Cranial vault defects
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 |
|---|---|---|
| Active CoilThe patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains. | Other | Active Coil |
| ShamThe patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses. | Other | Sham |
Primary outcome
Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
Time frame: One week and three months after rTMS.
3 secondary outcomes
Evidence of improvement on Executive Function processes measured by cognitive evaluation.
Time frame: one week and 3 months.
Evidence of improvement on Motor Coordination measured by cognitive evaluation.
Time frame: one week and three months.
Changes in cortical excitability measured by single and paired-pulse TMS
Time frame: one week and three months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Derived from this study: PubMed 33343483Rodrigues PA, Zaninotto AL, Ventresca HM, Neville IS, Hayashi CY, Brunoni AR, de Paula Guirado VM, Teixeira MJ, Paiva WS. The Effects of Repetitive Transcranial Magnetic Stimulation on Anxiety in Patients With Moderate to Severe Traumatic Brain Injury: A Post-hoc Analysis of a Randomized Clinical Trial. Front Neurol. 2020 Dec 4;11:564940. doi: 10.3389/fneur.2020.564940. eCollection 2020.
- Derived from this study: PubMed 31175209Neville IS, Zaninotto AL, Hayashi CY, Rodrigues PA, Galhardoni R, Ciampi de Andrade D, Brunoni AR, Amorim RLO, Teixeira MJ, Paiva WS. Repetitive TMS does not improve cognition in patients with TBI: A randomized double-blind trial. Neurology. 2019 Jul 9;93(2):e190-e199. doi: 10.1212/WNL.0000000000007748. Epub 2019 Jun 7.
- Derived from this study: PubMed 26438108Neville IS, Hayashi CY, El Hajj SA, Zaninotto AL, Sabino JP, Sousa LM Jr, Nagumo MM, Brunoni AR, Shieh BD, Amorim RL, Teixeira MJ, Paiva WS. Repetitive Transcranial Magnetic Stimulation (rTMS) for the cognitive rehabilitation of traumatic brain injury (TBI) victims: study protocol for a randomized controlled trial. Trials. 2015 Oct 5;16:440. doi: 10.1186/s13063-015-0944-2.
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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.
Wellingson S Paiva, MD study chair
University of Sao Paulo
Iuri N Ribeiro, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Coil in people with Traumatic Brain Injury and Diffuse Axonal Injury, run by University of Sao Paulo 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: finished, as of the sponsor's last update on 15 Aug 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test) (time frame: One week and three months after rTMS.). 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 NCT02167971, which also lists 3 linked publications.
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 15 Aug 2017.