Cerebellar tDCS for SRPCS Treatment

November 27, 2023 updated by: Justin Deters, University of Iowa

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Thorsten of Rudroff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
Standing Balance Test
Time Frame: 2 weeks
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
2 weeks
Flanker Inhibitory Control Test
Time Frame: 2 weeks
Assessment of Cognition/
2 weeks
Dimensional Change Card Sorting Test
Time Frame: 2 weeks
Assessment of Cognition
2 weeks
List Sorting Working Memory Test
Time Frame: 2 weeks
Assessment of Cognition
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimensional Change Card Sorting Test
Time Frame: 2 and 4 week follow ups
Assessment of Cognition
2 and 4 week follow ups
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.
2 and 4 week follow ups
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.
2 and 4 week follow ups
Flanker Inhibitory Control Test
Time Frame: 2 and 4 week follow ups
Assessment of Cognition
2 and 4 week follow ups
List Sorting Working Memory Test
Time Frame: 2 and 4 week follow ups
Assessment of Cognition
2 and 4 week follow ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202011163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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