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Active, not recruitingNCT04760899Updated Mar 21, 2025

Cerebellar TDCS for SRPCS Treatment

An interventional study of Transcranial Direct Current Stimulation in Post-Concussion Syndrome, sponsored by University of Iowa. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by University of Iowa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Post-Concussion Syndrome
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In context

Post-Concussion Syndrome

132 studies on the registry are indexed under Post-Concussion Syndrome; 33 are open to participants now.

This study's enrollment of 31 is below the median of 52 across 110 interventional studies indexed under Post-Concussion Syndrome.

Browse Post-Concussion Syndrome studies →

Lead sponsor

University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sign Informed Consent Document
  2. Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18-30.
  3. Diagnosed with a concussion by a doctor greater than or equal to 1 month ago.
  4. Concussion occurring during a sport/recreational activity
  5. Meet the ICD-10 diagnostic criteria for Post Concussion Syndrome:

    1. history of a traumatic brain injury at least a month in the past
    2. 3 or more of the following symptoms: headaches, dizziness, fatigue, irritability, insomnia, concentration, memory difficulty
  6. Rivermead Post Concussion Questionnaire score of at least 21 at baseline.
  7. Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
  8. Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history.
  9. Able to use and be contacted by telephone
  10. Able to speak, read, and understand English, and complete questionnaires in English.

Healthy Controls

  1. No history of mild traumatic brain injury or diagnosed concussion within the last year.
  2. Not suffering from any PCS symptoms related to a brain injury
  3. No History of a psychiatric condition (other than mild to moderate anxiety or depression)
  4. Currently on no prescribed psychoactive medications
  5. Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
  6. Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history.
  7. Able to use and be contacted by telephone
  8. Able to speak, read, and understand English, and complete questionnaires in English

Exclusion criteria

Exclusion Criteria:

    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.
  1. Pregnancy 8. No known fissures or holes in the skull 9. No metallic objects or implanted devices in the skull
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
31 participants (actual)

Study arms

  • Active comparator
    Active Group

    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.

    Device: Transcranial Direct Current Stimulation

  • Sham comparator
    Sham Group

    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.

    Device: Transcranial Direct Current Stimulation

  • No intervention
    Healthy Controls

    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.

Interventions

  • DeviceTranscranial Direct Current Stimulation

    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.

    Also known as: tDCS

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

  2. Standing Balance Test

    Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.

    Time frame: 2 weeks

  3. Flanker Inhibitory Control Test

    Assessment of Cognition/

    Time frame: 2 weeks

  4. Dimensional Change Card Sorting Test

    Assessment of Cognition

    Time frame: 2 weeks

  5. List Sorting Working Memory Test

    Assessment of Cognition

    Time frame: 2 weeks

Secondary outcomes

  1. Dimensional Change Card Sorting Test

    Assessment of Cognition

    Time frame: 2 and 4 week follow ups

  2. 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.

    Time frame: 2 and 4 week follow ups

  3. Standing Balance Scale

    Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.

    Time frame: 2 and 4 week follow ups

  4. Flanker Inhibitory Control Test

    Assessment of Cognition

    Time frame: 2 and 4 week follow ups

  5. List Sorting Working Memory Test

    Assessment of Cognition

    Time frame: 2 and 4 week follow ups

07

Study locations

1 site
  • Thorsten of Rudroff
    Iowa City, Iowa 52240, United States
08

References and documents

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 32083597 ↗
  • DePadilla 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 29927909 ↗
  • Doroszkiewicz 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 32962513 ↗
  • Eagle SR, Kontos AP, Collins MW, Connaboy C, Flanagan S. Network Analysis of Sport-related Concussion Research During the Past Decade (2010-2019). J Athl Train. 2020 Nov 5. doi: 10.4085/280-20. Online ahead of print. PubMed 33150356 ↗
  • Chen 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 32712533 ↗
  • Willer 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 16901381 ↗
  • Fregni 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 15999258 ↗
  • Demirtas-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 21691215 ↗
  • Laidi 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 32256404 ↗
  • Polinder 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 30619066 ↗
  • Maas 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 29122524 ↗
  • Romero 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 24998337 ↗
  • Jo 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 19620953 ↗
  • Dhaliwal 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 26379560 ↗
  • Rushby 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 32114899 ↗
  • Liebrand 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 ↗
  • Workman CD, Fietsam AC, Rudroff T. Different Effects of 2 mA and 4 mA Transcranial Direct Current Stimulation on Muscle Activity and Torque in a Maximal Isokinetic Fatigue Task. Front Hum Neurosci. 2020 Jun 25;14:240. doi: 10.3389/fnhum.2020.00240. eCollection 2020. PubMed 32714170 ↗
  • Antal A, Nitsche MA, Paulus W. Transcranial direct current stimulation and the visual cortex. Brain Res Bull. 2006 Feb 15;68(6):459-63. doi: 10.1016/j.brainresbull.2005.10.006. Epub 2005 Nov 2. PubMed 16459203 ↗
  • Hummel FC, Celnik P, Pascual-Leone A, Fregni F, Byblow WD, Buetefisch CM, Rothwell J, Cohen LG, Gerloff C. Controversy: Noninvasive and invasive cortical stimulation show efficacy in treating stroke patients. Brain Stimul. 2008 Oct;1(4):370-82. doi: 10.1016/j.brs.2008.09.003. Epub 2008 Oct 9. PubMed 20633395 ↗
  • Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614. PubMed 21343407 ↗
  • Liebetanz D, Koch R, Mayenfels S, Konig F, Paulus W, Nitsche MA. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7. doi: 10.1016/j.clinph.2009.01.022. Epub 2009 Apr 28. PubMed 19403329 ↗
  • Workman CD, Fietsam AC, Rudroff T. Tolerability and Blinding of Transcranial Direct Current Stimulation in People with Parkinson's Disease: A Critical Review. Brain Sci. 2020 Jul 20;10(7):467. doi: 10.3390/brainsci10070467. PubMed 32698528 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04760899
Lead sponsor
University of Iowa
Responsible party
Justin Deters (Principal Investigator, University of Iowa) — Principal investigator
First posted
Feb 18, 2021
Start date
Mar 1, 2021
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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