Status:
ACTIVE_NOT_RECRUITING
Cerebellar TDCS for SRPCS Treatment
Lead Sponsor:
University of Iowa
Conditions:
Post-Concussion Syndrome
Eligibility:
All Genders
18-30 years
Phase:
NA
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-relate...
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 consecu...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04760899
Start Date
March 1 2021
End Date
July 1 2027
Last Update
March 21 2025
Active Locations (1)
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1
Thorsten of Rudroff
Iowa City, Iowa, United States, 52240