Clinical trial NCT04760899: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-Concussion Syndrome
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 2 weeks
measure: Standing Balance Test
timeFrame: 2 weeks
measure: Flanker Inhibitory Control Test
timeFrame: 2 weeks
measure: Dimensional Change Card Sorting Test
timeFrame: 2 weeks
measure: List Sorting Working Memory Test
timeFrame: 2 weeks
Secondary outcomes:
measure: Dimensional Change Card Sorting Test
timeFrame: 2 and 4 week follow ups
measure: Berg Balance Scale
timeFrame: 2 and 4 week follow ups
measure: Standing Balance Scale
timeFrame: 2 and 4 week follow ups
measure: Flanker Inhibitory Control Test
timeFrame: 2 and 4 week follow ups
measure: List Sorting Working Memory Test
timeFrame: 2 and 4 week follow ups
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Thorsten of Rudroff
state: Iowa
Study officials:
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