Post-Treatment Lyme DiseaseNCT06915324
Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
A study testing Transcranial Direct Current Stimulation (tDCS) and Cognitive training in people with Post-Treatment Lyme Disease, run by Columbia University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Treatment Lyme Disease
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medical illness over the last 12 months (e.g., cancer, acute myocardial infarction, labile hypertension) b. Any severe skin disorder or skin sensitive area near stimulation locations (e.g. forehead)
- Neurologic: Any of the following:
- 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
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- 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.
- Psychiatric: Any of the following:
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Columbia University Department of Psychiatry
New York, New York, 10032
Alex Wetmore, BA, 646-774-7503, aw3661@cumc.columbia.edu
Mara Kuvaldina, PhD, 646-774-8108, mk4480@cumc.columbia.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94110
Piper Chase, BA, 203-822-2116, piper.chase@ucsf.edu
Felicia Chow, MD
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) of Brain Fog in Patients With Post Treatment Lyme Disease
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.
Read the detailed description
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).
Processing speed has been shown to be one of the primary areas of cognition affected by PTLD and may be a critical component of "brain fog," an everyday term for the fuzzy/scattered thinking, lack of mental sharpness and forgetfulness commonly reported by PTLD patients. Deficits in processing speed may also relate to fatigue and have broader effects on other aspects of cognitive performance including problems with memory and language.
This study will enroll participants with PTLD (definitive, probable, possible) who will be randomly assigned to one of two treatment groups at a 1:1 ratio. The at-home treatment duration is 30 minutes daily for 20 sessions spanning approximately 4 weeks. Group 1 will receive active transcranial direct current stimulation (tDCS) combined with computer-based cognitive training. Group 2 will receive sham tDCS combined with computer-based cognitive training. The cognitive training exercises are personalized to each user's performance level and are aimed at improving cognitive performance by improving information processing speed.
The study will assess changes in cognitive functioning in the context of tDCS treatment using both formal neuropsychological tests as well as questionnaires regarding cognitive lapses in everyday situations. In addition, the study will be examining whether tDCS will lead to improvements in other aspects of functioning such as mood, fatigue and pain symptoms as measured by clinical rating scales.
- Conditions
- Post-Treatment Lyme Disease
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Cognitive training
- Keywords
- tDCS, Cognitive training, Neuromodulation, Brain Fog, Brain Stimulation, Lyme Disease, Chronic Lyme
- Medical subject headings
- Post-Lyme Disease Syndrome, Mental Fatigue, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) is delivered by a device that has a user-friendly interface and a large-button keypad, making it is easy to use at home. The device delivers a weak electrical current of 2.0 mA that is transmitted through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are easily placed through a headset.
The active stimulation session lasts 30 minutes.
The inactive (sham) stimulation session will also last 30 minutes.
Cognitive trainingBehavioural
The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). There are 20 sessions, each 30 minutes a day, conducted over approximately 4 weeks. The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training and active tDCS | Experimental | The cognitive training and brain stimulation sessions are conducted at home at the same time over 30 minutes, 5 days/week, for 4 weeks for a total of 20 sessions.
Transcranial direct current stimulation (tDCS) is delivered by a user-friendly device; the participant wears a head-band that allows delivery of a weak electrical current (2mA) through two electrode patches over the forehead. The active stimulation session lasts 30 minutes.
The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive training |
| Cognitive training and sham tDCS | Sham comparator | The cognitive training and brain stimulation sessions are conducted at home at the same time over 30 minutes, 5 days/week, for 4 weeks for a total of 20 sessions.
Transcranial direct current stimulation (tDCS) is delivered by a user-friendly device; the participant wears a head-band that allows delivery of a weak electrical current (2mA) through two electrode patches over the forehead. The inactive (sham) stimulation session lasts 30 minutes.
The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coding test scale score for acute treatment
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.
Measured: 4 weeks
Coding test scale score for post-treatment follow-up
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.
Measured: 12 weeks
Secondary outcomes (9)
Composite score of the reaction time measures
Composite score of the reaction time measures (Coding, Choice Reaction Time, Grooved Pegboard, and the Test of Silent Word Reading Fluency-2), measured in Z-scores from -4 to +4 with a higher score representing a better outcome.
Measured: 4 weeks
Fatigue Severity Scale (FSS) Score
This is a self-reported measure of fatigue. This measure consists of 9 items inquiring about the severity of fatigue in different situations over the past week. Scores for each item range from 1 to 7 where 1 indicates strong disagreement and 7 strong agreements. Higher scores indicate higher levels of fatigue.
Measured: 4 weeks
General Symptom Questionnaire (GSQ-30) Score
This is a 30 item self-reported measure of symptom burden. The measure asks participants to rate how bothered they have been with a particular symptom over a 2-week time frame. The total score ranges from 0 to 120 with higher score indicating higher symptom severity.
Measured: 4 weeks
Generalized Anxiety Disorder-7 (GAD-7) Score
This is a measure of severity of anxiety. It has 7 seven items, and the scores range from 0 to 21 with higher scores indicating more pronounced anxiety.
Measured: 4 weeks
PROMIS Emotional Distress-Depression-Short Form Score
This is a self-reported measure that assesses symptoms of depression during the past 7 days. It has 8 items. Each item ranges from 1 (never) to 5 (always) with higher scores representing more pronounced depression.
Measured: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-29) symptom summary score
The PROMIS-29 is a 29 item self-report measure covering 7 symptom domains. The questions are ranked on a 5-point Likert Scale. The PROMIS-29 SPADE score represents the average T-score across the 5 SPADE (sleep disturbance, pain, anxiety, depression, and low energy/fatigue) domains with higher scores indicating greater symptom severity. The SPADE T-score ranges from 20-80 with higher scores indicating more symptom severity.
Measured: 4 weeks
Cognitive functioning z-score
Measures that include domains of cognitive function that are affected by processing speed (attention, memory, working memory and language fluency). Each measure has a raw score that is converted to z-score that ranges from -4 to +4 with higher score representing a better outcome.
Measured: 4 weeks
Neuro-QoL Short Form v1.0 - Applied Cognition Score
This is a self-reported measure that assesses cognitive function across neurological conditions. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10. Higher score indicates a greater degree of reported cognitive difficulties.
Measured: 4 weeks
Brain Fog Visual Analogue Scale (Brain Fog VAS) Score
This is self-reported measure of cognitive complaints severity (brain fog). It measures the period over the last 7 days, score ranges from 0 to 10 with higher score indicating a higher severity of reported brain fog.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start14 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Treatment Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive computer-based cognitive exercises to improve processing speed. During the cognitive exercises, half of the participants receive concomitant active tDCS while the other half of the participants receive concomitant sham tDCS.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Steven & Alexandra Cohen Foundation
- Responsible party
- Principal investigator, Brian A Fallon, Columbia University
- Investigators
- Brian A Fallon, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915324
- Sponsor's protocol ID
- AAAV1512
- Status last verified
- May 2026
- First submitted
- 2 Apr 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) of Brain Fog in Patients With Post Treatment Lyme Disease
- ClinicalTrials.gov ID
- NCT06915324
- Acronym / sponsor ID
- AAAV1512
- Conditions
- Post-Treatment Lyme Disease
- Keywords
- tDCS, Cognitive training, Neuromodulation, Brain Fog, Brain Stimulation, Lyme Disease, Chronic Lyme
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Steven & Alexandra Cohen Foundation
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Processing speed has been shown to be one of the primary areas of cognition affected by PTLD and may be a critical component of "brain fog," an everyday term for the fuzzy/scattered thinking, lack of mental sharpness and forgetfulness commonly reported by PTLD patients. Deficits in processing speed may also relate to fatigue and have broader effects on other aspects of cognitive performance including problems with memory and language.
This study will enroll participants with PTLD (definitive, probable, possible) who will be randomly assigned to one of two treatment groups at a 1:1 ratio. The at-home treatment duration is 30 minutes daily for 20 sessions spanning approximately 4 weeks. Group 1 will receive active transcranial direct current stimulation (tDCS) combined with computer-based cognitive training. Group 2 will receive sham tDCS combined with computer-based cognitive training. The cognitive training exercises are personalized to each user's performance level and are aimed at improving cognitive performance by improving information processing speed.
The study will assess changes in cognitive functioning in the context of tDCS treatment using both formal neuropsychological tests as well as questionnaires regarding cognitive lapses in everyday situations. In addition, the study will be examining whether tDCS will lead to improvements in other aspects of functioning such as mood, fatigue and pain symptoms as measured by clinical rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants receive computer-based cognitive exercises to improve processing speed. During the cognitive exercises, half of the participants receive concomitant active tDCS while the other half of the participants receive concomitant sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| Cognitive training and active tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive trainingThe cognitive training and brain stimulation sessions are conducted at home at the same time over 30 minutes, 5 days/week, for 4 weeks for a total of 20 sessions. Transcranial direct current stimulation (tDCS) is delivered by a user-friendly device; the participant wears a head-band that allows delivery of a weak electrical current (2mA) through two electrode patches over the forehead. The active stimulation session lasts 30 minutes. The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations. |
| Cognitive training and sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive trainingThe cognitive training and brain stimulation sessions are conducted at home at the same time over 30 minutes, 5 days/week, for 4 weeks for a total of 20 sessions. Transcranial direct current stimulation (tDCS) is delivered by a user-friendly device; the participant wears a head-band that allows delivery of a weak electrical current (2mA) through two electrode patches over the forehead. The inactive (sham) stimulation session lasts 30 minutes. The cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (22 listed)
- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medical illness over the last 12 months (e.g., cancer, acute myocardial infarction, labile hypertension) b. Any severe skin disorder or skin sensitive area near stimulation locations (e.g. forehead)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Transcranial direct current stimulation (tDCS) is delivered by a device that has a user-friendly interface and a large-button keypad, making it is easy to use at home. The device delivers a weak electrical current of 2.0 mA that is transmitted through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are easily placed through a headset. The active stimulation session lasts 30 minutes. The inactive (sham) stimulation session will also last 30 minutes. | Device | Cognitive training and active tDCS, Cognitive training and sham tDCS |
| Cognitive trainingThe cognitive training tasks are administered via a computer-based program BrainHQ (Posit Science). There are 20 sessions, each 30 minutes a day, conducted over approximately 4 weeks. The BrainHQ adaptive cognitive training tasks have been previously associated with improved processing speed in other populations. | Behavioural | Cognitive training and active tDCS, Cognitive training and sham tDCS |
Primary outcome
Coding test scale score for acute treatment
Time frame: 4 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-up
Time frame: 12 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.
9 secondary outcomes
Composite score of the reaction time measures
Time frame: 4 weeks
Fatigue Severity Scale (FSS) Score
Time frame: 4 weeks
General Symptom Questionnaire (GSQ-30) Score
Time frame: 4 weeks
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: 4 weeks
PROMIS Emotional Distress-Depression-Short Form Score
Time frame: 4 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-29) symptom summary score
Time frame: 4 weeks
Cognitive functioning z-score
Time frame: 4 weeks
Neuro-QoL Short Form v1.0 - Applied Cognition Score
Time frame: 4 weeks
Brain Fog Visual Analogue Scale (Brain Fog VAS) Score
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Lyme Clinical Trials Network websiteLink provided by the sponsor.
- Columbia Univ Medical Center Lyme tDCS StudyLink provided by the sponsor.
- UCSF Lyme tDCS StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian A Fallon, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and Cognitive training in people with Post-Treatment Lyme Disease, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Kuvaldina, PhD (646-774-8108, mk4480@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coding test scale score for acute treatment (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.