Cerebellar TDCS for SRPCS Treatment

NCT ID: NCT04760899

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2027-07-31

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.

Conditions

Post-Concussion Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

tDCS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Justin Deters

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thorsten of Rudroff

Iowa City, Iowa, United States

Countries

United States

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Other Identifiers

202011163

Identifier Type: -

Identifier Source: org_study_id