Transcranial Direct Current Stimulation for Post-Treatment Lyme Disease

This study is looking into a new way to help with thinking problems, often called "brain fog," that can happen after Lyme disease, even after antibiotic treatment. This condition is known as Post-Treatment Lyme Disease (PTLD). You would receive a combination of two treatments: transcranial direct current stimulation (tDCS), which is a device that sends a weak electrical current, and computer-based cognitive (thinking) training using a program called BrainHQ. The main goal is to see if this combination can improve how quickly you process information. To join, you need to be between 18 and 70 years old, have a history of Lyme disease with cognitive symptoms, and have received at least two courses of antibiotics for Lyme disease. The study aims to enroll 110 people.

Study design: This is a pilot study that will randomly assign 110 participants to one of two groups: active tDCS with cognitive training, or sham tDCS with cognitive training.
What's involved: You would participate in at-home treatment for 30 minutes daily for 20 sessions, over approximately 4 weeks.
Compensation: Not stated in the trial record.
Follow-up: Your processing speed will be measured at 4 weeks (after treatment) and again at 12 weeks (for follow-up).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

Recruiting

NAAges 18–70InterventionalTreatment

Columbia University

~110 participants

Updated 2026-05-06 on ClinicalTrials.gov

What's tested:Transcranial Direct Current Stimulation (tDCS)Cognitive training

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Coding test scale score for acute treatment

Measured over 4 weeks

+1 more outcome measured

Conditions

Post-Treatment Lyme Disease

NCT06915324

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Columbia University Department of Psychiatry
New York, New Yorkstudy coordinator listed
Recruiting
University of California, San Francisco
San Francisco, Californiastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Brian A Fallon, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Mara Kuvaldina, PhD

[email protected]

646-774-8108

Email the study team

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Eligibility criteria

Inclusion

History of diagnosis of Lyme disease by a health care provider, meeting criteria for either definite or probable or possible LD

Willingness to provide documentation of prior LD testing and/or related medical records

Total prior antibiotic treatment for LD was at least 2 courses of antibiotic therapy

Have cognitive symptoms attributed to Lyme disease that have persisted or returned despite antibiotic therapy

Current cognitive symptoms interfere with function and/or cause distress

Have evidence of slowed processing speed on a screening measure

Participant is willing to be off of antibiotic treatment for tick-borne disease for at least 4 weeks prior to final determination of study eligibility and for the duration of the 12-week study.

Participant expresses willingness to not start new medications that might affect treatment outcome during the trial (unless medically necessary), and willingness to inform study staff regarding any changes in medication

Live in the US or Canada and comfortable speaking English

Age 18-70

Stable and continuous access to internet service

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

Able to commit to the 12-week study period (4 weeks of training sessions and an 8-week post treatment visit)

Estimated intellectual ability \>= 85

Exclusion

History of traumatic brain injury with persistent post-concussive symptoms

History of seizure disorder or recent (\<5 years) seizure history

History of neurosurgery to the head

Chronic headaches or migraines of moderate to severe intensity within the last month

Post stroke deficits that may interfere with assessment

Any progressive neurodegenerative disorder or other neurological disorders that may interfere with assessment at discretion of the investigator.

History of intellectual disability, or other developmental neurological condition associated with cognitive impairment

Current primary psychiatric disorder that would interfere with ability to participate

Current alcohol or other substance use disorder

Current suicide risk as assessed by the C-SSRS (any level)

History of suicidal behavior over the last year

History of a diagnosis of a psychotic disorder, mania or bipolar disorder

Depression rating of moderate or severe at screening

Currently taking opiate-based medications, dissociative drugs (prescribed or illicit), or other medication considered likely to interfere with treatment outcome at the discretion of the investigator. The use of a stable dose of benzodiazepines, anticholinergic agents and non-narcotic pain medications is permitted. The use of an occasional dose of these medications is also permitted, but not within 48 hours of neurocognitive study assessments.

Participants whose current daily medication regimen has not been stable for a minimum of 4 weeks prior to final determination of study eligibility

Medical device implanted in the head (such as a Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator), or metal implants in the head or neck

Inadequate visual or motor skills needed for regular computer use or to operate study equipment, or inability to provide informed consent

Individuals who are pregnant or breastfeeding or planning to become pregnant

Lifestyle Considerations: Participants not willing to refrain from beginning, resuming or increasing non study cognitive training or cognitive enhancing supplements/medications or other therapies that might affect treatment outcome

What this trial measures

Coding test scale score for acute treatment4 weeks
The WAIS-IV Coding test is part of the Processing Speed Subtest and consists of three measured abilities, including visual-motor coordination, motor and mental speed, and visual working memory. In this coding task, participants using the key provided at the top of the exercise form draw the symbol under the corresponding number. Subtests yielding scaled scores that sum to derive the full-scale score. The score is the number of correct symbols from 0-133 drawn within a period of 120 seconds. The standardized T-score ranges from 1 to 19 with higher numbers indicating a better outcome/performance.
Coding test scale score for post-treatment follow-up12 weeks
The WAIS-IV Coding test is part of the Processing Speed Subtest and consists of three measured abilities, including visual-motor coordination, motor and mental speed, and visual working memory. In this coding task, participants using the key provided at the top of the exercise form draw the symbol under the corresponding number. Subtests yielding scaled scores that sum to derive the full-scale score. The score is the number of correct symbols from 0-133 drawn within a period of 120 seconds. The standardized T-score ranges from 1 to 19 with higher numbers indicating a better outcome/performance.

Trialytics