Cerebellar TDCS for SRPCS Treatment

Not Applicable

Active, not recruiting

• Conditions: Post-Concussion Syndrome
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT04760899
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Study Start: 2021-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Group	Transcranial Direct Current Stimulation	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.
Sham Group	Transcranial Direct Current 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.

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	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.
List Sorting Working Memory Test	2 weeks	Assessment of Cognition
Flanker Inhibitory Control Test	2 weeks	Assessment of Cognition/
Dimensional Change Card Sorting Test	2 weeks	Assessment of Cognition
Standing Balance Test	2 weeks	Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.

Secondary Outcome Measures

Name	Time	Method
Dimensional Change Card Sorting Test	2 and 4 week follow ups	Assessment of Cognition
Standing Balance Scale	2 and 4 week follow ups	Balance Assessment. Outcomes of this test are overall postural sway translated into a normalized t-score.
Berg Balance Scale	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.
Flanker Inhibitory Control Test	2 and 4 week follow ups	Assessment of Cognition
List Sorting Working Memory Test	2 and 4 week follow ups	Assessment of Cognition

Trial Locations

Locations (1)

Thorsten of Rudroff; 🇺🇸 Iowa City, Iowa, United States