Post-Concussion SyndromeNCT04760899
Cerebellar TDCS for SRPCS Treatment
A study testing Transcranial Direct Current Stimulation in people with Post-Concussion Syndrome, run by University of Iowa at 1 site in United States.
Trial summary
This study is investigating the immediate and long-term effects of bilateral cerebellar transcranial direct current stimulation on cognition, balance, and symptom severity in people with sports-related post-concussion syndrome. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Jul 2027
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign Informed Consent Document
- Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18-30.
- Diagnosed with a concussion by a doctor greater than or equal to 1 month ago.
- Concussion occurring during a sport/recreational activity
- Meet the ICD-10 diagnostic criteria for Post Concussion Syndrome:
- history of a traumatic brain injury at least a month in the past
Show all 21Show fewer
- 3 or more of the following symptoms: headaches, dizziness, fatigue, irritability, insomnia, concentration, memory difficulty
- Rivermead Post Concussion Questionnaire score of at least 21 at baseline.
- Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
- Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history.
- Able to use and be contacted by telephone
- Able to speak, read, and understand English, and complete questionnaires in English.
- Healthy Controls
- No history of mild traumatic brain injury or diagnosed concussion within the last year.
- Not suffering from any PCS symptoms related to a brain injury
- No History of a psychiatric condition (other than mild to moderate anxiety or depression)
- Currently on no prescribed psychoactive medications
- Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
- Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history.
- Able to use and be contacted by telephone
- Able to speak, read, and understand English, and complete questionnaires in English
Who cannot join
- 1. History/presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia 2. Currently diagnosed drug and/or alcohol addiction 3. Active Psychosis 4. History of a psychiatric condition (other than mild to moderate anxiety or depression) 5. Currently on no prescribed psychoactive medications 6. Not in any kind of memory improvement program or therapy during study participation.
- 7. Pregnancy 8. No known fissures or holes in the skull 9. No metallic objects or implanted devices in the skull
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Cerebellar Transcranial Direct Current Stimulation (tDCS) for the Treatment of Sports-Related Post-Concussion Syndrome (SRPCS)
This study is investigating the immediate and long-term effects of bilateral cerebellar transcranial direct current stimulation on cognition, balance, and symptom severity in people with sports-related post-concussion syndrome. The central hypothesis is that tDCS will provide improvements in cognitive deficits, balance, and overall symptom attenuation in people with SRPCS both acutely and at 2 and 4 week follow ups. The researchers further hypothesize that cerebellar tDCS will ameliorate the symptoms of people with SRPCS.
Read the detailed description
The long term goal is to develop an effective and broadly applicable treatment modality for athletes who develop SPRCS. The objective of this study is to investigate the effects of multiple (5 consecutive daily) sessions of 2 milliampere (mA) right cerebellar tDCS on cognitive deficits, balance, and overall attenuation of symptoms on people with SRPCS. Cognitive deficits will be assessed with the N-back Working Memory test, list sorting test, and dimensional change card test. Balance deficits will be assessed with the Berg Balance Scale and Standing Balance Test (SBT), and symptoms will be assessed via the Rivermead Post-Concussion Symptom Questionnaire (RPQ). The cognitive and balance tasks are taken from the NIH motor toolbox and have been shown to be the most important for health and success in school and work, and the RPQ is one of the most widely used SRPCS evaluation tools. The central hypothesis is that tDCS will provide improvements in cognitive deficits, balance, and overall symptom attenuation in people with SRPCS both acutely and at 2 and 4 week follow ups. The researchers further hypothesize that cerebellar tDCS will ameliorate the symptoms of people with SRPCS. The rationale is that the results will improve the quality of life of these patients and may prevent impairment of cognitive function later in life.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Post-Concussion Syndrome
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
Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | This group will receive the active form of tDCS. The tDCS will be administered with the anode over the right lobule of the cerebellum, and the cathode over the left lobule of the cerebellum. Stimulation will be administered for a twenty minute period that does not include the 30 second ramp up at the beginning and end of the stimulation. Receives: Device: Transcranial Direct Current Stimulation |
| Sham Group | Sham comparator | This group will receive the sham form of tDCS. The electrodes will be placed in the same montage as in the Active group, however the stimulation parameters are different. For this group, the stimulation will be ramped up to the target intensity over thirty seconds at the beginning, then immediately ramp down over thirty seconds. The stimulation will then remain off for the next twenty minutes. After twenty minutes the stimulation will ramp up to the target intensity and then back down over thirty seconds. Receives: Device: Transcranial Direct Current Stimulation |
| Healthy Controls | No intervention | These will be age and sex-matched healthy controls who only come in for the baseline visit in order to provide comparative values with which to confirm adequate impairment in our diseased population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Balance Assessment. This is a 14 item test with scores from 0 to 4, with 4 being no inhibition at all. The max score on this test is 56, higher scores indicating better balance.
Measured: 2 weeks
Standing Balance Test
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Measured: 2 weeks
Flanker Inhibitory Control Test
Assessment of Cognition/
Measured: 2 weeks
Dimensional Change Card Sorting Test
Assessment of Cognition
Measured: 2 weeks
List Sorting Working Memory Test
Assessment of Cognition
Measured: 2 weeks
Secondary outcomes (5)
Dimensional Change Card Sorting Test
Assessment of Cognition
Measured: 2 and 4 week follow ups
Berg Balance Scale
Balance Assessment. This is a 14 item test with scores from 0 to 4, with 4 being no inhibition at all. The max score on this test is 56, higher scores indicating better balance.
Measured: 2 and 4 week follow ups
Standing Balance Scale
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Measured: 2 and 4 week follow ups
Flanker Inhibitory Control Test
Assessment of Cognition
Measured: 2 and 4 week follow ups
List Sorting Working Memory Test
Assessment of Cognition
Measured: 2 and 4 week follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Deters, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760899
- Sponsor's protocol ID
- 202011163
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Conder A, Conder R, Friesen C. Neurorehabilitation of Persistent Sport-Related Post-Concussion Syndrome. NeuroRehabilitation. 2020;46(2):167-180. doi: 10.3233/NRE-192966.
PubMed 32083597DePadilla L, Miller GF, Jones SE, Peterson AB, Breiding MJ. Self-Reported Concussions from Playing a Sport or Being Physically Active Among High School Students - United States, 2017. MMWR Morb Mortal Wkly Rep. 2018 Jun 22;67(24):682-685. doi: 10.15585/mmwr.mm6724a3.
PubMed 29927909Doroszkiewicz C, Gold D, Green R, Tartaglia MC, Ma J, Tator CH. Anxiety, Depression, and Quality of Life: A Long-Term Follow-Up Study of Patients with Persisting Concussion Symptoms. J Neurotrauma. 2021 Feb 15;38(4):493-505. doi: 10.1089/neu.2020.7313. Epub 2020 Nov 2.
PubMed 32962513Chen CL, Lin MY, Huda MH, Tsai PS. Effects of cognitive behavioral therapy for adults with post-concussion syndrome: A systematic review and meta-analysis of randomized controlled trials. J Psychosom Res. 2020 Sep;136:110190. doi: 10.1016/j.jpsychores.2020.110190. Epub 2020 Jul 17.
PubMed 32712533Willer B, Leddy JJ. Management of concussion and post-concussion syndrome. Curr Treat Options Neurol. 2006 Sep;8(5):415-26. doi: 10.1007/s11940-006-0031-9.
PubMed 16901381Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
PubMed 15999258Demirtas-Tatlidede A, Vahabzadeh-Hagh AM, Bernabeu M, Tormos JM, Pascual-Leone A. Noninvasive brain stimulation in traumatic brain injury. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):274-92. doi: 10.1097/HTR.0b013e318217df55.
PubMed 21691215Laidi C, Levenes C, Suarez-Perez A, Fevrier C, Durand F, Bouaziz N, Januel D. Cognitive Impact of Cerebellar Non-invasive Stimulation in a Patient With Schizophrenia. Front Psychiatry. 2020 Mar 17;11:174. doi: 10.3389/fpsyt.2020.00174. eCollection 2020.
PubMed 32256404Polinder S, Cnossen MC, Real RGL, Covic A, Gorbunova A, Voormolen DC, Master CL, Haagsma JA, Diaz-Arrastia R, von Steinbuechel N. A Multidimensional Approach to Post-concussion Symptoms in Mild Traumatic Brain Injury. Front Neurol. 2018 Dec 19;9:1113. doi: 10.3389/fneur.2018.01113. eCollection 2018.
PubMed 30619066Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available.
PubMed 29122524Romero Lauro LJ, Rosanova M, Mattavelli G, Convento S, Pisoni A, Opitz A, Bolognini N, Vallar G. TDCS increases cortical excitability: direct evidence from TMS-EEG. Cortex. 2014 Sep;58:99-111. doi: 10.1016/j.cortex.2014.05.003. Epub 2014 Jun 6.
PubMed 24998337Jo JM, Kim YH, Ko MH, Ohn SH, Joen B, Lee KH. Enhancing the working memory of stroke patients using tDCS. Am J Phys Med Rehabil. 2009 May;88(5):404-9. doi: 10.1097/PHM.0b013e3181a0e4cb.
PubMed 19620953Dhaliwal SK, Meek BP, Modirrousta MM. Non-Invasive Brain Stimulation for the Treatment of Symptoms Following Traumatic Brain Injury. Front Psychiatry. 2015 Aug 26;6:119. doi: 10.3389/fpsyt.2015.00119. eCollection 2015.
PubMed 26379560Rushby JA, De Blasio FM, Logan JA, Wearne T, Kornfeld E, Wilson EJ, Loo C, Martin D, McDonald S. tDCS effects on task-related activation and working memory performance in traumatic brain injury: A within group randomized controlled trial. Neuropsychol Rehabil. 2021 Jun;31(5):814-836. doi: 10.1080/09602011.2020.1733620. Epub 2020 Mar 2.
PubMed 32114899Liebrand M, Karabanov A, Antonenko D, Floel A, Siebner HR, Classen J, Kramer UM, Tzvi E. Beneficial effects of cerebellar tDCS on motor learning are associated with altered putamen-cerebellar connectivity: A simultaneous tDCS-fMRI study. Neuroimage. 2020 Dec;223:117363. doi: 10.1016/j.neuroimage.2020.117363. Epub 2020 Sep 9.
PubMed 32919057
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Cerebellar Transcranial Direct Current Stimulation (tDCS) for the Treatment of Sports-Related Post-Concussion Syndrome (SRPCS)
- ClinicalTrials.gov ID
- NCT04760899
- Acronym / sponsor ID
- 202011163
- Conditions
- Post-Concussion Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Feb 2021 (actual)
- 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.
This study is investigating the immediate and long-term effects of bilateral cerebellar transcranial direct current stimulation on cognition, balance, and symptom severity in people with sports-related post-concussion syndrome. The central hypothesis is that tDCS will provide improvements in cognitive deficits, balance, and overall symptom attenuation in people with SRPCS both acutely and at 2 and 4 week follow ups. The researchers further hypothesize that cerebellar tDCS will ameliorate the symptoms of people with SRPCS.
Detailed description
The long term goal is to develop an effective and broadly applicable treatment modality for athletes who develop SPRCS. The objective of this study is to investigate the effects of multiple (5 consecutive daily) sessions of 2 milliampere (mA) right cerebellar tDCS on cognitive deficits, balance, and overall attenuation of symptoms on people with SRPCS. Cognitive deficits will be assessed with the N-back Working Memory test, list sorting test, and dimensional change card test. Balance deficits will be assessed with the Berg Balance Scale and Standing Balance Test (SBT), and symptoms will be assessed via the Rivermead Post-Concussion Symptom Questionnaire (RPQ). The cognitive and balance tasks are taken from the NIH motor toolbox and have been shown to be the most important for health and success in school and work, and the RPQ is one of the most widely used SRPCS evaluation tools. The central hypothesis is that tDCS will provide improvements in cognitive deficits, balance, and overall symptom attenuation in people with SRPCS both acutely and at 2 and 4 week follow ups. The researchers further hypothesize that cerebellar tDCS will ameliorate the symptoms of people with SRPCS. The rationale is that the results will improve the quality of life of these patients and may prevent impairment of cognitive function later in life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Device: Transcranial Direct Current StimulationThis group will receive the active form of tDCS. The tDCS will be administered with the anode over the right lobule of the cerebellum, and the cathode over the left lobule of the cerebellum. Stimulation will be administered for a twenty minute period that does not include the 30 second ramp up at the beginning and end of the stimulation. |
| Sham Group | Sham comparator | Device: Transcranial Direct Current StimulationThis group will receive the sham form of tDCS. The electrodes will be placed in the same montage as in the Active group, however the stimulation parameters are different. For this group, the stimulation will be ramped up to the target intensity over thirty seconds at the beginning, then immediately ramp down over thirty seconds. The stimulation will then remain off for the next twenty minutes. After twenty minutes the stimulation will ramp up to the target intensity and then back down over thirty seconds. |
| Healthy Controls | No intervention | –These will be age and sex-matched healthy controls who only come in for the baseline visit in order to provide comparative values with which to confirm adequate impairment in our diseased population. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Sign Informed Consent Document
- Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18-30.
- Diagnosed with a concussion by a doctor greater than or equal to 1 month ago.
- Concussion occurring during a sport/recreational activity
- Meet the ICD-10 diagnostic criteria for Post Concussion Syndrome:
Key exclusion criteria (2 listed)
- 1. History/presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia 2. Currently diagnosed drug and/or alcohol addiction 3. Active Psychosis 4. History of a psychiatric condition (other than mild to moderate anxiety or depression) 5. Currently on no prescribed psychoactive medications 6. Not in any kind of memory improvement program or therapy during study participation.
- 7. Pregnancy 8. No known fissures or holes in the skull 9. No metallic objects or implanted devices in the skull
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: tDCSTranscranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability. | Device | Active Group, Sham Group |
Primary outcome
Berg Balance Scale
Time frame: 2 weeks
Balance Assessment. This is a 14 item test with scores from 0 to 4, with 4 being no inhibition at all. The max score on this test is 56, higher scores indicating better balance.
Standing Balance Test
Time frame: 2 weeks
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Flanker Inhibitory Control Test
Time frame: 2 weeks
Assessment of Cognition/
Dimensional Change Card Sorting Test
Time frame: 2 weeks
Assessment of Cognition
List Sorting Working Memory Test
Time frame: 2 weeks
Assessment of Cognition
5 secondary outcomes
Dimensional Change Card Sorting Test
Time frame: 2 and 4 week follow ups
Berg Balance Scale
Time frame: 2 and 4 week follow ups
Standing Balance Scale
Time frame: 2 and 4 week follow ups
Flanker Inhibitory Control Test
Time frame: 2 and 4 week follow ups
List Sorting Working Memory Test
Time frame: 2 and 4 week follow ups
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 21 Mar 2025.
- Background: PubMed 32083597Conder A, Conder R, Friesen C. Neurorehabilitation of Persistent Sport-Related Post-Concussion Syndrome. NeuroRehabilitation. 2020;46(2):167-180. doi: 10.3233/NRE-192966.
- Background: PubMed 29927909DePadilla L, Miller GF, Jones SE, Peterson AB, Breiding MJ. Self-Reported Concussions from Playing a Sport or Being Physically Active Among High School Students - United States, 2017. MMWR Morb Mortal Wkly Rep. 2018 Jun 22;67(24):682-685. doi: 10.15585/mmwr.mm6724a3.
- Background: PubMed 32962513Doroszkiewicz C, Gold D, Green R, Tartaglia MC, Ma J, Tator CH. Anxiety, Depression, and Quality of Life: A Long-Term Follow-Up Study of Patients with Persisting Concussion Symptoms. J Neurotrauma. 2021 Feb 15;38(4):493-505. doi: 10.1089/neu.2020.7313. Epub 2020 Nov 2.
- Background: PubMed 32712533Chen CL, Lin MY, Huda MH, Tsai PS. Effects of cognitive behavioral therapy for adults with post-concussion syndrome: A systematic review and meta-analysis of randomized controlled trials. J Psychosom Res. 2020 Sep;136:110190. doi: 10.1016/j.jpsychores.2020.110190. Epub 2020 Jul 17.
- Background: PubMed 16901381Willer B, Leddy JJ. Management of concussion and post-concussion syndrome. Curr Treat Options Neurol. 2006 Sep;8(5):415-26. doi: 10.1007/s11940-006-0031-9.
- Background: PubMed 15999258Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
- Background: PubMed 21691215Demirtas-Tatlidede A, Vahabzadeh-Hagh AM, Bernabeu M, Tormos JM, Pascual-Leone A. Noninvasive brain stimulation in traumatic brain injury. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):274-92. doi: 10.1097/HTR.0b013e318217df55.
- Background: PubMed 32256404Laidi C, Levenes C, Suarez-Perez A, Fevrier C, Durand F, Bouaziz N, Januel D. Cognitive Impact of Cerebellar Non-invasive Stimulation in a Patient With Schizophrenia. Front Psychiatry. 2020 Mar 17;11:174. doi: 10.3389/fpsyt.2020.00174. eCollection 2020.
- Background: PubMed 30619066Polinder S, Cnossen MC, Real RGL, Covic A, Gorbunova A, Voormolen DC, Master CL, Haagsma JA, Diaz-Arrastia R, von Steinbuechel N. A Multidimensional Approach to Post-concussion Symptoms in Mild Traumatic Brain Injury. Front Neurol. 2018 Dec 19;9:1113. doi: 10.3389/fneur.2018.01113. eCollection 2018.
- Background: PubMed 29122524Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available.
- Background: PubMed 24998337Romero Lauro LJ, Rosanova M, Mattavelli G, Convento S, Pisoni A, Opitz A, Bolognini N, Vallar G. TDCS increases cortical excitability: direct evidence from TMS-EEG. Cortex. 2014 Sep;58:99-111. doi: 10.1016/j.cortex.2014.05.003. Epub 2014 Jun 6.
- Background: PubMed 19620953Jo JM, Kim YH, Ko MH, Ohn SH, Joen B, Lee KH. Enhancing the working memory of stroke patients using tDCS. Am J Phys Med Rehabil. 2009 May;88(5):404-9. doi: 10.1097/PHM.0b013e3181a0e4cb.
- Individual participant dataSharing planned: No
Related trials for Post-Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Post-Concussion Syndrome, run by University of Iowa at 1 site in United States.
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 21 inclusion and 2 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 21 Mar 2025. 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 United States. 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.
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?
Berg Balance Scale (time frame: 2 weeks). The study lists 5 primary outcomes in all. 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 NCT04760899, which also lists 21 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 21 Mar 2025.