Brain Stimulation + Cognitive Training for Lyme Disease

Overseen By Elana Farrell, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Opiates, Dissociatives, others

Disqualifiers: Cancer, Seizure, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with ongoing memory and thinking problems after Lyme disease treatment. The study combines brain stimulation, specifically Transcranial Direct Current Stimulation (tDCS), with engaging computer games designed to enhance brain processing speed. Participants will perform these activities at home for four weeks, with researchers later assessing whether any improvements persist. Individuals who have had Lyme disease, completed at least two rounds of antibiotics, and continue to experience cognitive issues affecting daily life may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve cognitive recovery for Lyme disease patients.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications. Participants must be off antibiotic treatment for tick-borne disease for at least 4 weeks before the study and during the 12-week study. You should not start new medications that might affect the treatment outcome unless medically necessary, and you must inform the study staff about any medication changes.

What prior data suggests that this brain stimulation and cognitive training approach is safe for individuals with Lyme disease?

Previous studies have shown that cognitive training helps people think and react faster. The BrainHQ program used in this trial builds on these studies and aims to improve brain function.

Transcranial direct current stimulation (tDCS) uses a mild electrical current applied to the head to enhance brain function. Research shows it is non-invasive, generally well-tolerated, and may help with mood, fatigue, and pain, common in people with long-term Lyme disease symptoms.

Both treatments have been used safely in different settings, and studies have not reported any serious side effects. This makes them promising options for further exploration in helping those with ongoing Lyme disease symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine cognitive training with Transcranial Direct Current Stimulation (tDCS), offering a novel approach for addressing cognitive issues associated with Lyme disease. Unlike typical medications that target symptoms through pharmaceuticals, tDCS uses a gentle electrical current to potentially enhance brain function. This non-invasive technique can be administered at home, making it convenient and accessible. Additionally, the cognitive tasks through BrainHQ are tailored to improve processing speed, which could lead to better cognitive outcomes for patients. This combination of brain stimulation and cognitive exercises represents a fresh, promising strategy distinct from conventional drug treatments.

What evidence suggests that this trial's treatments could be effective for cognitive symptoms in Lyme disease?

Research has shown that brain exercises can enhance cognitive speed. The BrainHQ program, used in this trial, has proven successful with other groups. Users often experience clearer thinking and quicker responses.

Additionally, studies have found that transcranial direct current stimulation (tDCS) can alleviate cognitive issues. It has reduced symptoms like depression and fatigue in other conditions. In this trial, some participants will receive active tDCS combined with brain exercises, potentially boosting brain function, while others will receive sham tDCS for comparison. ^{1 2 3 5 6}

Who Is on the Research Team?

Felicia C Chow, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals who have cognitive symptoms after being treated for Lyme disease, known as Post Treatment Lyme Disease (PTLD). Participants will engage in at-home cognitive training with either real or sham brain stimulation over a period of 4 weeks.

Inclusion Criteria

Adequate home facilities (enough space, access to quiet and distraction-free area)

Stable and continuous access to internet service

I have completed at least 2 rounds of antibiotics for Lyme disease.

Exclusion Criteria

I have long-lasting symptoms from a past brain injury.

I haven't had any unstable chronic illnesses like cancer or heart issues in the past year.

I have severe skin issues or sensitivity where a device would be placed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcranial direct current stimulation (tDCS) combined with computer-based cognitive training at home for 4 weeks

4 weeks

20 sessions (at home)

Follow-up

Participants are monitored for sustained treatment benefits in processing speed and other cognitive functions

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive training
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if transcranial direct current stimulation (tDCS), paired with cognitive training games, can improve processing speed in PTLD patients. It compares the effects of active and sham stimulation to see if any improvements last 8 weeks post-treatment.

How Is the Trial Designed?

Group I: Cognitive training and active tDCS Experimental Treatment 2 Interventions

The cognitive training and brain stimulation sessions are conducted at home at the same time over 30 minutes, 5 days/week, for 4 weeks for a total of 20 sessions. Transcranial direct current stimulation (tDCS) is delivered by a user-friendly device; the participant wears a head-band that allows delivery of a weak electrical current (2mA) through two electrode patches over the forehead. The active stimulation session lasts 30 minutes. The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations.

Group II: Cognitive training and sham tDCS Placebo Group 2 Interventions

The cognitive training and brain stimulation sessions are conducted at home at the same time over 30 minutes, 5 days/week, for 4 weeks for a total of 20 sessions. Transcranial direct current stimulation (tDCS) is delivered by a user-friendly device; the participant wears a head-band that allows delivery of a weak electrical current (2mA) through two electrode patches over the forehead. The inactive (sham) stimulation session lasts 30 minutes. The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Bay Area Lyme Foundation

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06915324

Transcranial Direct Current Stimulation for Post Treatment ... The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations.

2. withpower.com withpower.com/trial/phase-lyme-disease-5-2025-d050c

Brain Stimulation + Cognitive Training for Lyme Disease Research shows that tDCS has been effective in improving symptoms like depression, fatigue, and pain in conditions such as Multiple Sclerosis, suggesting it ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT06915324

Transcranial Direct Current Stimulation for Post Treatment ... The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations.

4. aviv-clinics.com aviv-clinics.com/blog/science/brain-games-effective/

Brain Games: How Cognitive Training Enhances ... ... data shows cognitive training can improve quality of life and ward off cognitive decline. Dietary changes and exercise can also help ...

5. medrxiv.org medrxiv.org/content/10.1101/2024.12.16.24319088v1

Early brain changes in Lyme disease are associated with ... After antibiotic treatment, 10-20% of patients develop post-treatment Lyme disease (PTLD). Neurological symptoms are commonly reported in PTLD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11095283/

Neuropsychiatric Manifestations and Cognitive Decline in ... The purpose of this review was to report the neuropsychiatric manifestations, cognitive decline, and effects of a delayed diagnosis on symptom severity in ...