Actively Recruiting
Transcranial Direct Current Stimulation (tDCS) of Brain Fog in Patients With Post Treatment Lyme Disease
Led by Columbia University · Updated on 2026-05-06
110
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
S
Steven & Alexandra Cohen Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to treat cognitive symptoms that continue after antibiotic treatment for Post Treatment Lyme Disease (PTLD). This pilot study focuses on improving processing speed, a key cognitive area affected in PTLD that contributes to "brain fog," fatigue, memory, and language problems. Participants with different levels of PTLD diagnosis will be randomly assigned to one of two groups to compare treatment effects. Participants will complete 20 sessions over approximately 4 weeks at home, combining computer-based cognitive training with either active or sham transcranial direct current stimulation (tDCS). The tDCS device delivers a mild electrical current through a headset to the forehead for 30 minutes, while the cognitive training uses personalized BrainHQ tasks designed to improve processing speed. The study compares daily active stimulation plus training with daily sham stimulation plus training. During the study, participants will be assessed through neuropsychological tests and questionnaires to measure changes in cognitive function, mood, fatigue, and pain. Outcomes include scores from coding tests at 4 and 12 weeks and various symptom scales. The total participation lasts 12 weeks, including 4 weeks of treatment and an 8-week follow-up to see if benefits persist. Researchers will also monitor daily adherence and medication changes throughout the trial.
CONDITIONS
Brief Title
Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of diagnosis of Lyme disease by a healthcare provider (definite, probable, or possible)
- Willingness to provide documentation of prior Lyme disease testing or medical records
- At least two courses of prior antibiotic treatment for Lyme disease
- Persistent or returning cognitive symptoms attributed to Lyme disease despite antibiotic therapy
- Current cognitive symptoms interfere with function or cause distress
- Evidence of slowed processing speed on a screening test
- Willingness to be off antibiotic treatment for tick-borne disease for at least 4 weeks before eligibility and during the 12-week study
- Willingness to avoid starting new medications that may affect treatment outcome during the trial unless medically necessary
- Living in the US or Canada and comfortable speaking English
- Age between 18 and 70 years
- Stable and continuous internet access at home
- Adequate home environment with enough space and quiet for study activities
- Ability to commit to the 12-week study period including training and follow-up
- Estimated intellectual ability of 85 or higher
You will not qualify if you...
- Unstable non-Lyme-related chronic medical illness in the past 12 months (e.g., cancer, heart attack, labile blood pressure)
- Severe skin disorders or sensitive skin near stimulation sites
- History of traumatic brain injury with lasting symptoms
- History of seizure disorder or seizures within the last 5 years
- History of neurosurgery to the head
- Moderate to severe chronic headaches or migraines in the past month
- Post-stroke deficits affecting assessments
- Progressive neurodegenerative or neurological disorders that interfere with study
- Intellectual disability or developmental neurological conditions with cognitive impairment
- Current primary psychiatric disorders that interfere with participation
- Current substance use disorders
- Current suicide risk or history of suicidal behavior within the past year
- Diagnosis of psychotic disorder, mania, or bipolar disorder
- Moderate or severe depression at screening
- Use of opiate-based or dissociative medications or others interfering with treatment outcome
- Unstable daily medication regimen in the 4 weeks before eligibility
- Medical devices implanted in the head or neck or metal implants there
- Inadequate vision or motor skills for computer or study devices
- Pregnancy, breastfeeding, or planning pregnancy
- Unwillingness to avoid new cognitive training, supplements, or therapies that affect treatment outcome during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants complete 20 daily sessions of combined transcranial direct current stimulation (tDCS) and computer-based cognitive training at home. Each session lasts approximately 30 minutes and is conducted 5 days per week over about 4 weeks.
20 sessions conducted at home, 5 days per week
Duration - 8 weeks
Participants are assessed for changes in cognitive functioning, mood, fatigue, and other symptoms after treatment completion.
1 follow-up visit
Trial Site Locations
Total: 2 locations
1
University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
2
Columbia University Department of Psychiatry
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Mara Kuvaldina, PhD
E
Ellen Brown, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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