Traumatic Brain InjuryPhase 2tDCS/PPCSNCT02292589
Brain Stimulation for Mild Traumatic Brain Injury
A Phase 2 study testing Frontal Stimulation and Temporal Stimulation in people with Traumatic Brain Injury and Post-Concussion Symptoms, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the early effects of transcranial direct current stimulation (tDCS) in patients with mild traumatic brain injury and persistent post concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive function(inhibitory control). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Post-Concussion Symptoms
- What is being tested?
- Frontal Stimulation and Temporal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- history of mild traumatic brain injury on hospital admission
- subjective complain of memory and executive function
- must be able to sign the Informed Consent Form
Who cannot join
- under or over age limits
- no specific complain of memory and executive function
- history of major depression(Beck Inventory>35)
- drug addiction
- uncontrolled epilepsy
- presence of any metallic prosthesis implant
- presence of cochlear implant
- not able to sign the Informed Consent Form
Trial locations and contacts
1 site in 1 country.
Brazil1 site
HC University of Sao Paulo - Medical School
São Paulo, São Paulo, 05410-000
About this study
Official title: tDCS in Patients With Mild Traumatic Brain Injury and Persistent Post Concussion Syndrome: Randomized Crossover Trial
The purpose of this study is to determine the early effects of transcranial direct current stimulation (tDCS) in patients with mild traumatic brain injury and persistent post concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive function(inhibitory control).
Read the detailed description
This is a randomized crossover trial of patients with mild TBI (mTBI) sustaining PPCS. It will be recruited twenty adult patients who will receive three sessions of anodal tDCS: left dorsolateral prefrontal cortex, left temporal cortex(with an intensity of 1.5 mA for 20 min) and sham stimulation(intensity of 1.5 mA for 30 seconds only). Sessions will be performed with at least 7 days of interval(wash out period) in a randomized order. Patients who meet the inclusion criteria will be assessed with a neuropsychological evaluation - battery tests include Beck Depression Scale, Hopkins Verbal Learning(HVLT), Stroop test and digit, letters and numbers sequence. A new battery of computerized neuropsychological test will be performed before and immediately after each stimulation(HVLT, Wechsler memory scale, Inhibitory control test(ICT) and block-tapping test.
- Conditions
- Traumatic Brain Injury, Post-Concussion Symptoms
- Being tested
- Frontal Stimulation, Temporal Stimulation, Sham Stimulation
- Keywords
- Traumatic Brain Injury, Post concussion syndrome, Transcranial Direct Current Stimulation, Neuromodulation
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontal StimulationDevice
The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.
Temporal StimulationDevice
The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.
Sham StimulationDevice
The patient will receive anodal tDCS over the occipital area for 30 seconds only and then it will be turned off without the patient's knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Frontal Stimulation | Experimental | Left dorsolateral prefrontal cortex stimulation Receives: Device: Frontal Stimulation |
| Temporal Stimulation | Experimental | Left temporal cortex stimulation Receives: Device: Temporal Stimulation |
| Sham Stimulation | Experimental | Sham stimulation Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.
Measured: immediately after the stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2026 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robson L Amorim, MD, Principal investigator, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292589
- Sponsor's protocol ID
- RAHC-001
- Acronym
- tDCS/PPCS
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2014
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lesniak M, Polanowska K, Seniow J, Czlonkowska A. Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. J Head Trauma Rehabil. 2014 May-Jun;29(3):E20-9. doi: 10.1097/HTR.0b013e318292a4c2.
PubMed 23756431Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
PubMed 15753425McArthur DL, Chute DJ, Villablanca JP. Moderate and severe traumatic brain injury: epidemiologic, imaging and neuropathologic perspectives. Brain Pathol. 2004 Apr;14(2):185-94. doi: 10.1111/j.1750-3639.2004.tb00052.x.
PubMed 15193031Bajaj JS, Saeian K, Verber MD, Hischke D, Hoffmann RG, Franco J, Varma RR, Rao SM. Inhibitory control test is a simple method to diagnose minimal hepatic encephalopathy and predict development of overt hepatic encephalopathy. Am J Gastroenterol. 2007 Apr;102(4):754-60. doi: 10.1111/j.1572-0241.2007.01048.x. Epub 2007 Jan 11.
PubMed 17222319Datta SG, Pillai SV, Rao SL, Kovoor JM, Chandramouli BA. Post-concussion syndrome: Correlation of neuropsychological deficits, structural lesions on magnetic resonance imaging and symptoms. Neurol India. 2009 Sep-Oct;57(5):594-8. doi: 10.4103/0028-3886.57810.
PubMed 19934558Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and the State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996 Apr;29(4):453-7.
PubMed 8736107King NS. Post-concussion syndrome: clarity amid the controversy? Br J Psychiatry. 2003 Oct;183:276-8. doi: 10.1192/bjp.183.4.276. No abstract available.
PubMed 14519601Prigatano GP, Gale SD. The current status of postconcussion syndrome. Curr Opin Psychiatry. 2011 May;24(3):243-50. doi: 10.1097/YCO.0b013e328344698b.
PubMed 21346569Wood RL. Understanding the 'miserable minority': a diasthesis-stress paradigm for post-concussional syndrome. Brain Inj. 2004 Nov;18(11):1135-53. doi: 10.1080/02699050410001675906.
PubMed 15545210de Amorim RLO, Brunoni AR, de Oliveira MAF, Zaninotto ALC, Nagumo MM, Guirado VMP, Neville IS, Benute GRG, de Lucia MCS, Paiva WS, de Andrade AF, Teixeira MJ. Transcranial Direct Current Stimulation for Post-Concussion Syndrome: Study Protocol for a Randomized Crossover Trial. Front Neurol. 2017 May 2;8:164. doi: 10.3389/fneur.2017.00164. eCollection 2017.
PubMed 28512443
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS in Patients With Mild Traumatic Brain Injury and Persistent Post Concussion Syndrome: Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02292589
- Acronym / sponsor ID
- tDCS/PPCS / RAHC-001
- Conditions
- Traumatic Brain Injury, Post-Concussion Symptoms
- Keywords
- Traumatic Brain Injury, Post concussion syndrome, Transcranial Direct Current Stimulation, Neuromodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Nov 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 the early effects of transcranial direct current stimulation (tDCS) in patients with mild traumatic brain injury and persistent post concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive function(inhibitory control).
Detailed description
This is a randomized crossover trial of patients with mild TBI (mTBI) sustaining PPCS. It will be recruited twenty adult patients who will receive three sessions of anodal tDCS: left dorsolateral prefrontal cortex, left temporal cortex(with an intensity of 1.5 mA for 20 min) and sham stimulation(intensity of 1.5 mA for 30 seconds only). Sessions will be performed with at least 7 days of interval(wash out period) in a randomized order. Patients who meet the inclusion criteria will be assessed with a neuropsychological evaluation - battery tests include Beck Depression Scale, Hopkins Verbal Learning(HVLT), Stroop test and digit, letters and numbers sequence. A new battery of computerized neuropsychological test will be performed before and immediately after each stimulation(HVLT, Wechsler memory scale, Inhibitory control test(ICT) and block-tapping test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Frontal Stimulation | Experimental | Device: Frontal StimulationLeft dorsolateral prefrontal cortex stimulation |
| Temporal Stimulation | Experimental | Device: Temporal StimulationLeft temporal cortex stimulation |
| Sham Stimulation | Experimental | Device: Sham StimulationSham stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- history of mild traumatic brain injury on hospital admission
- subjective complain of memory and executive function
- must be able to sign the Informed Consent Form
Key exclusion criteria (8 listed)
- under or over age limits
- no specific complain of memory and executive function
- history of major depression(Beck Inventory>35)
- drug addiction
- uncontrolled epilepsy
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 |
|---|---|---|
| Frontal StimulationThe patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes. | Device | Frontal Stimulation |
| Temporal StimulationThe patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes. | Device | Temporal Stimulation |
| Sham StimulationThe patient will receive anodal tDCS over the occipital area for 30 seconds only and then it will be turned off without the patient's knowledge. | Device | Sham Stimulation |
Primary outcome
Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
Time frame: immediately after the stimulation
HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 23756431Lesniak M, Polanowska K, Seniow J, Czlonkowska A. Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. J Head Trauma Rehabil. 2014 May-Jun;29(3):E20-9. doi: 10.1097/HTR.0b013e318292a4c2.
- Background: PubMed 15753425Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
- Background: PubMed 15193031McArthur DL, Chute DJ, Villablanca JP. Moderate and severe traumatic brain injury: epidemiologic, imaging and neuropathologic perspectives. Brain Pathol. 2004 Apr;14(2):185-94. doi: 10.1111/j.1750-3639.2004.tb00052.x.
- Background: PubMed 17222319Bajaj JS, Saeian K, Verber MD, Hischke D, Hoffmann RG, Franco J, Varma RR, Rao SM. Inhibitory control test is a simple method to diagnose minimal hepatic encephalopathy and predict development of overt hepatic encephalopathy. Am J Gastroenterol. 2007 Apr;102(4):754-60. doi: 10.1111/j.1572-0241.2007.01048.x. Epub 2007 Jan 11.
- Background: PubMed 19934558Datta SG, Pillai SV, Rao SL, Kovoor JM, Chandramouli BA. Post-concussion syndrome: Correlation of neuropsychological deficits, structural lesions on magnetic resonance imaging and symptoms. Neurol India. 2009 Sep-Oct;57(5):594-8. doi: 10.4103/0028-3886.57810.
- Background: PubMed 8736107Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and the State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996 Apr;29(4):453-7.
- Background: PubMed 14519601King NS. Post-concussion syndrome: clarity amid the controversy? Br J Psychiatry. 2003 Oct;183:276-8. doi: 10.1192/bjp.183.4.276. No abstract available.
- Background: PubMed 21346569Prigatano GP, Gale SD. The current status of postconcussion syndrome. Curr Opin Psychiatry. 2011 May;24(3):243-50. doi: 10.1097/YCO.0b013e328344698b.
- Background: PubMed 15545210Wood RL. Understanding the 'miserable minority': a diasthesis-stress paradigm for post-concussional syndrome. Brain Inj. 2004 Nov;18(11):1135-53. doi: 10.1080/02699050410001675906.
- Derived from this study: PubMed 28512443de Amorim RLO, Brunoni AR, de Oliveira MAF, Zaninotto ALC, Nagumo MM, Guirado VMP, Neville IS, Benute GRG, de Lucia MCS, Paiva WS, de Andrade AF, Teixeira MJ. Transcranial Direct Current Stimulation for Post-Concussion Syndrome: Study Protocol for a Randomized Crossover Trial. Front Neurol. 2017 May 2;8:164. doi: 10.3389/fneur.2017.00164. eCollection 2017.
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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.
Robson L Amorim, MD principal investigator
University of Sao Paulo Medical School
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 Frontal Stimulation and Temporal Stimulation in people with Traumatic Brain Injury and Post-Concussion Symptoms, run by University of Sao Paulo General Hospital 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 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
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 of patient's episodic memory and executive function measured by neuropsychological test (time frame: immediately after the stimulation). 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 NCT02292589, which also lists 10 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 30 Jan 2024.