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Cerebellar tDCS for SRPCS Treatment

Primary Purpose

Post-Concussion Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Thorsten of RudroffRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Active Group

Sham Group

Healthy Controls

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dimensional Change Card Sorting Test
Assessment of Cognition
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.
Standing Balance Scale
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Flanker Inhibitory Control Test
Assessment of Cognition
List Sorting Working Memory Test
Assessment of Cognition

Full Information

First Posted
February 15, 2021
Last Updated
June 20, 2022
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT04760899
Brief Title
Cerebellar tDCS for SRPCS Treatment
Official Title
Bilateral Cerebellar Transcranial Direct Current Stimulation (tDCS) for the Treatment of Sports-Related Post-Concussion Syndrome (SRPCS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Title
Standing Balance Test
Description
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Time Frame
2 weeks
Title
Flanker Inhibitory Control Test
Description
Assessment of Cognition/
Time Frame
2 weeks
Title
Dimensional Change Card Sorting Test
Description
Assessment of Cognition
Time Frame
2 weeks
Title
List Sorting Working Memory Test
Description
Assessment of Cognition
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Dimensional Change Card Sorting Test
Description
Assessment of Cognition
Time Frame
2 and 4 week follow ups
Title
Berg Balance Scale
Description
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
Title
Standing Balance Scale
Description
Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Time Frame
2 and 4 week follow ups
Title
Flanker Inhibitory Control Test
Description
Assessment of Cognition
Time Frame
2 and 4 week follow ups
Title
List Sorting Working Memory Test
Description
Assessment of Cognition
Time Frame
2 and 4 week follow ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 7. Pregnancy 8. No known fissures or holes in the skull 9. No metallic objects or implanted devices in the skull
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin R Deters, MS
Phone
319-367-0746
Email
justin-deters@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thorsten Rudroff, PhD
Phone
319-367-0746
Email
thorsten-rudroff@uiowa.edu
Facility Information:
Facility Name
Thorsten of Rudroff
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten o Rudroff, PhD
Phone
720-532-3701
Email
thorsten-rudroff@uiowa.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Cerebellar tDCS for SRPCS Treatment

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