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Active, Not Recruiting

NCT Number: NCT04760899

Cerebellar TDCS for SRPCS Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thorsten of Rudroff

Iowa City, Iowa, 52240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

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

Treatment and study plan

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.

Other names: tDCS

Primary outcomes

  1. 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.

  2. Standing Balance Test

    Time frame: 2 weeks

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

  3. Flanker Inhibitory Control Test

    Time frame: 2 weeks

    Assessment of Cognition/

  4. Dimensional Change Card Sorting Test

    Time frame: 2 weeks

    Assessment of Cognition

  5. List Sorting Working Memory Test

    Time frame: 2 weeks

    Assessment of Cognition

Secondary outcomes

  1. Dimensional Change Card Sorting Test

    Time frame: 2 and 4 week follow ups

    Assessment of Cognition

  2. Berg Balance Scale

    Time frame: 2 and 4 week follow ups

    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.

  3. Standing Balance Scale

    Time frame: 2 and 4 week follow ups

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

  4. Flanker Inhibitory Control Test

    Time frame: 2 and 4 week follow ups

    Assessment of Cognition

  5. List Sorting Working Memory Test

    Time frame: 2 and 4 week follow ups

    Assessment of Cognition

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2021
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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