Cerebellar tDCS for SRPCS Treatment

Post-Concussion Syndrome Clinical Trial

Official title:

Bilateral Cerebellar Transcranial Direct Current Stimulation (tDCS) for the Treatment of Sports-Related Post-Concussion Syndrome (SRPCS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04760899
• Other study ID #: 202011163
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Post-Concussion Syndrome
• Syndrome

Intervention

Device:
• Transcranial 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.

Locations

Country	Name	City	State
United States	Thorsten of Rudroff	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (22)

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Standing Balance Test	Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.	2 weeks
Primary	Flanker Inhibitory Control Test	Assessment of Cognition/	2 weeks
Primary	Dimensional Change Card Sorting Test	Assessment of Cognition	2 weeks
Primary	List Sorting Working Memory Test	Assessment of Cognition	2 weeks
Secondary	Dimensional Change Card Sorting Test	Assessment of Cognition	2 and 4 week follow ups
Secondary	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 and 4 week follow ups
Secondary	Standing Balance Scale	Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.	2 and 4 week follow ups
Secondary	Flanker Inhibitory Control Test	Assessment of Cognition	2 and 4 week follow ups
Secondary	List Sorting Working Memory Test	Assessment of Cognition	2 and 4 week follow ups