Actively Recruiting
Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
Led by Columbia University · Updated on 2026-05-06
110
Participants Needed
2
Research Sites
106 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
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.
CONDITIONS
Official Title
Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of Lyme disease diagnosis by a healthcare provider, meeting criteria for definite, probable, or possible Lyme disease
- Willingness to provide documentation of prior Lyme disease testing or related medical records
- At least two courses of prior antibiotic treatment for Lyme disease
- Presence of cognitive symptoms attributed to Lyme disease that persist or have returned after antibiotic therapy
- Current cognitive symptoms interfere with function or cause distress
- Evidence of slowed processing speed on a screening test
- Willingness to stop antibiotic treatment for tick-borne disease at least 4 weeks before final eligibility and during the 12-week study
- Willingness to avoid starting new medications that may affect study outcome unless medically necessary and to inform study staff of any medication changes
- Residency in the US or Canada and ability to speak English comfortably
- Age between 18 and 70 years
- Stable and continuous internet access
- Adequate home environment with enough space and a quiet, distraction-free area
- Ability to commit to the full 12-week study period (4 weeks of training and 8 weeks post-treatment follow-up)
- Estimated intellectual ability of 85 or higher
You will not qualify if you...
- Unstable chronic medical illnesses unrelated to Lyme disease within the last 12 months (e.g., cancer, heart attack, labile hypertension)
- Severe skin disorders or sensitive skin near stimulation sites (e.g., forehead)
- 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 within the past month
- Post-stroke deficits that interfere with assessments
- Progressive neurodegenerative or other neurological disorders that may affect assessments
- Intellectual disability or developmental neurological condition with cognitive impairment
- Current primary psychiatric disorder interfering with participation
- Current alcohol or substance use disorder
- Any current suicide risk or history of suicidal behavior in the past year
- History of psychotic disorders, mania, or bipolar disorder
- Moderate or severe depression at screening
- Current use of opiate-based medications, dissociative drugs, or other medications likely to interfere with treatment outcome (stable benzodiazepines, anticholinergic agents, and non-narcotic pain medications allowed with restrictions)
- Medication regimen not stable for at least 4 weeks prior to final eligibility
- Implanted medical devices in the head or neck (e.g., deep brain stimulator, vagus nerve stimulator) or metal implants in these areas
- Inadequate visual or motor skills to use a computer or study equipment or inability to give informed consent
- Pregnancy, breastfeeding, or plans to become pregnant
- Unwillingness to refrain from non-study cognitive training, cognitive enhancing supplements, medications, or other therapies that might affect treatment outcome during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
Ellen Brown, BA
CONTACT
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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