Brain Stimulation + Cognitive Training for Lyme Disease

Recruiting at 1 trial location

Overseen By Ellen Brown, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Opiates, Dissociatives, others

Disqualifiers: Unstable chronic illness, Seizure history, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 20

Duration: 4 weeks

110 Participants Needed

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 brain fog and slow thinking caused by Lyme disease, even after antibiotic treatment. It combines mild electrical brain stimulation using a headband (known as Transcranial Direct Current Stimulation, or tDCS) with engaging computer-based brain games. The goal is to determine if this combination can enhance thinking speed and if the effects persist over time. Individuals who have experienced Lyme disease and continue to struggle with mental clarity, impacting their daily lives, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mental clarity for those affected by Lyme disease.

Will I have to stop taking my current medications?

Participants must stop taking antibiotics for tick-borne diseases at least 4 weeks before the study and during the 12-week study period. They should not start new medications that might affect the treatment outcome unless medically necessary, and they must inform the study staff of any medication changes. Some medications, like opiates and dissociative drugs, are not allowed, but stable doses of benzodiazepines and non-narcotic pain medications are permitted.

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

Studies have shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. This non-invasive treatment does not involve surgery or entering the body. It uses a weak electrical current applied to the scalp. Research indicates that most people experience only mild side effects, such as tingling or itching on the skin where the electrodes are placed. Serious side effects are rare.

In past studies, researchers tested tDCS on different groups and found no major safety concerns. This suggests it is a safe option for those looking to improve their thinking skills. However, as with any treatment, staying informed and discussing any concerns with healthcare professionals is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel combination of brain stimulation and cognitive training for Lyme disease. Unlike standard treatments like antibiotics, which target the bacterial cause of Lyme disease, this approach focuses on enhancing cognitive function through Transcranial Direct Current Stimulation (tDCS). This method uses a user-friendly device to deliver a gentle electrical current to the brain, potentially improving processing speed. The study also incorporates BrainHQ, a computer-based cognitive training program, which has shown promise in other settings. This trial could open up new avenues for addressing the cognitive symptoms of Lyme disease, offering a non-invasive and home-based treatment option.

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

This trial will compare the effects of cognitive training combined with active transcranial direct current stimulation (tDCS) to cognitive training with sham tDCS. Research has shown that tDCS can enhance thinking skills by applying a gentle electrical current to the scalp, boosting brain activity. Studies have found that tDCS, particularly when paired with brain training programs like BrainHQ, can increase information processing speed. BrainHQ exercises are recognized for enhancing mental performance, including thinking speed. Although specific data for Lyme disease patients is limited, early results in similar cases are encouraging. ^{1 2 5 6 7}

Who Is on the Research Team?

Brian A Fallon, MD

Principal Investigator

Columbia University

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

Live in the US or Canada and comfortable speaking English

Stable and continuous access to internet service

I agree to stop tick-borne disease antibiotics 4 weeks before and during the study.

Exclusion Criteria

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

Psychiatric: Current alcohol or other substance use disorder

I have a history of seizures or had a seizure in the last 5 years.

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

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if transcranial direct current stimulation (tDCS) combined with cognitive training 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?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Steven & Alexandra Cohen Foundation

Collaborator

Trials

10

Recruited

320+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) is a feasible and tolerable treatment for children aged 5 to 12 with language disorders, based on a study involving 14 children who received 10 sessions.

While tDCS had minimal side effects, the most common were tingling and itching (28.6%), along with acute mood changes (42.9%) and irritability (35.7%), indicating that while generally safe, monitoring for these effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of transcranial direct current stimulation use in children aged 5 to 12 years. Andrade, AC., Magnavita, GM., Allegro, JV., et al.[2014]

Transcranial direct current stimulation (tDCS) is a noninvasive technique that can significantly alter brain functions and has been studied in 340 clinical articles for various conditions, including depression, pain syndromes, and neurodegenerative diseases.

The review provides a comprehensive overview of the clinical applications of tDCS, detailing factors such as study design, sample size, and stimulation parameters, which can help guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive database of published tDCS clinical trials (2005-2016). Lefaucheur, JP.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

In a feasibility study involving 45 participants with multiple sclerosis, those receiving remotely-supervised transcranial direct current stimulation (RS-tDCS) alongside cognitive training showed significant improvements in complex attention and response variability compared to those who only received cognitive training.

The study suggests that RS-tDCS may enhance cognitive outcomes in MS patients, particularly in areas of complex attention, indicating its potential as a beneficial telerehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Charvet, L., Shaw, M., Dobbs, B., et al.[2022]

Transcranial direct current stimulation (tDCS) has been shown to be a promising treatment for depression and fatigue in Multiple Sclerosis, with a meta-analysis of 18 high-quality randomized controlled trials indicating it is moderately to highly recommendable due to its effectiveness and negligible side effects.

The study utilized the GRADE criteria and PICO model to evaluate tDCS treatments, highlighting its low-cost and easy-to-use nature, which supports its potential inclusion in medical therapies for conditions related to brain electrical activity imbalances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS randomized controlled trials in no-structural diseases: a quantitative review. Gianni, E., Bertoli, M., Simonelli, I., et al.[2021]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Cranial electrotherapy stimulation (CES) was tested as an add-on treatment for tic disorders (TD) in a study involving 62 patients aged 6-17 years, showing a reduction in tic severity after 4 weeks of treatment.

While both active CES and sham CES groups experienced improvements in tic severity, the difference was not statistically significant, suggesting that the observed benefits may be largely due to a placebo effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents. Wu, WJ., Wang, Y., Cai, M., et al.[2021]

Citations

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

Transcranial Direct Current Stimulation for Post Treatment ... The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic ...

2. columbia-lyme.org columbia-lyme.org/news/transcranial-direct-current-stimulation-tdcs

Transcranial Direct Current Stimulation (tDCS) | Lyme Disease This research study will assess a non-medication non-invasive intervention to improve cognitive functioning in people with persistent cognitive problems.

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06915324

Transcranial Direct Current Stimulation for Post Treatment ... Aim 1: The primary aim of this study is to assess whether the processing speed of individuals with PTLD can be enhanced by combining transcranial direct current ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT06997341

Transcranial Direct Current Stimulation for Post Treatment ... The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic ...

5. lymectn.org lymectn.org/Studies.aspx

Current Studies This clinical trial investigates the safety, tolerability, and clinical benefit of at home vagus nerve stimulation to reduce the burden of fatigue and other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and ...

7. trials.arthritis.org trials.arthritis.org/trials/NCT06915324

Transcranial Direct Current Stimulation for Post Treatment ... The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic ...