Brain Stimulation + Cognitive Training for Lyme Disease

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

55 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) 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 might help with similar symptoms in Lyme Disease. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with mild and temporary side effects like itching, tingling, and headaches. Studies have shown no serious adverse effects in over 33,200 sessions, even in potentially vulnerable groups like children and the elderly. ^{6 7 8 9 10}

How does the treatment of tDCS differ from other treatments for Lyme Disease?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive treatment that uses a low electrical current applied to the scalp to potentially alter brain function, unlike traditional drug treatments. It has been explored for various conditions like depression and multiple sclerosis, showing promise due to its low cost and ease of use, but its specific effects on Lyme Disease are still being studied. ^{1 3 5 11 12}

What is the purpose of this trial?

The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic treatment for Lyme disease (Post treatment Lyme Disease or PTLD). 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 stimulation (tDCS) with computer based cognitive training games. To achieve this aim, over a 4-week period, all individuals with PTLD will participate in at home adaptive cognitive training combined with either active stimulation or sham stimulation. Aim 2: To determine if treatment benefit in processing speed is sustained, the study will compare the sham and active groups 8 weeks after completion of study treatment.

Research Team

Brian A Fallon, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Live in the US or Canada and comfortable speaking English

Stable and continuous access to internet service

Exclusion Criteria

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

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

Psychiatric: Current alcohol or other substance use disorder

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

tDCS randomized controlled trials in no-structural diseases: a quantitative review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Inter- and Intra-individual Variability in Response to Transcranial Direct Current Stimulation (tDCS) at Varying Current Intensities. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prefrontal tDCS Decreases Pain in Patients with Multiple Sclerosis. [2022]

5. France pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

9. Netherlands 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of transcranial direct current stimulation use in children aged 5 to 12 years. [2014]

11. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation and exercises for treatment of chronic temporomandibular disorders: a blind randomised-controlled trial. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Reinterpreting published tDCS results in terms of a cranial and cervical nerve co-stimulation mechanism. [2023]