Cerebellar TDCS for SRPCS Treatment

NCT04760899 | Active Not Recruiting FDA Device

• 1 other identifier: 202011163
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (5)

• 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.

  2 weeks

• Standing Balance Test

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

  2 weeks

• Flanker Inhibitory Control Test

  Assessment of Cognition/

  2 weeks

• Dimensional Change Card Sorting Test

  Assessment of Cognition

  2 weeks

• List Sorting Working Memory Test

  Assessment of Cognition

  2 weeks

Secondary Outcomes (5)

• Dimensional Change Card Sorting Test

  2 and 4 week follow ups

• Berg Balance Scale

  2 and 4 week follow ups

• Standing Balance Scale

  2 and 4 week follow ups

• Flanker Inhibitory Control Test

  2 and 4 week follow ups

• List Sorting Working Memory Test

  2 and 4 week follow ups

Study Arms (3)

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.

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.

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.

Interventions

Transcranial Direct Current Stimulation DEVICE

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

Active Group; Sham Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• \- 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.
• \. Pregnancy 8. No known fissures or holes in the skull 9. No metallic objects or implanted devices in the skull

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Thorsten of Rudroff

Iowa City, Iowa, 52240, United States

Location

Related Publications (22)

• 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.

  PMID: 32083597 BACKGROUND

• 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.

  PMID: 29927909 BACKGROUND

• 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.

  PMID: 32962513 BACKGROUND

• 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.

  PMID: 33150356 BACKGROUND

• 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.

  PMID: 32712533 BACKGROUND

• 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.

  PMID: 16901381 BACKGROUND

• 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.

  PMID: 15999258 BACKGROUND

• 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.

  PMID: 21691215 BACKGROUND

• 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.

  PMID: 32256404 BACKGROUND

• 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.

  PMID: 30619066 BACKGROUND

• 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.

  PMID: 29122524 BACKGROUND

• 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.

  PMID: 24998337 BACKGROUND

• 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.

  PMID: 19620953 BACKGROUND

• 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.

  PMID: 26379560 BACKGROUND

• 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.

  PMID: 32114899 BACKGROUND

• 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.

  PMID: 32919057 BACKGROUND

• 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.

  PMID: 32714170 BACKGROUND

• 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.

  PMID: 16459203 BACKGROUND

• 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.

  PMID: 20633395 BACKGROUND

• Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.

  PMID: 21343407 BACKGROUND

• 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.

  PMID: 19403329 BACKGROUND

• 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.

  PMID: 32698528 BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)