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 range18 Years – 70 Years
SexALL
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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 (…
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