Transcranial Direct Current Stimulation for Post Treatment Lyme Disease (NCT06915324) | Clinical Trial Compass
RecruitingNot Applicable
Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
United States110 participantsStarted 2025-07-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
\- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medical illness over the last 12 months (…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coding test scale score for acute treatment
Timeframe: 4 weeks
2
Coding test scale score for post-treatment follow-up