Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

Last updated: April 2, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lyme Disease

Rash

Treatment

Cognitive training

Transcranial Direct Current Stimulation (tDCS)

Clinical Study ID

NCT06915324
AAAV1512
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of diagnosis of Lyme disease by a health care provider, meeting criteria foreither definite or probable or possible LD

  • Willingness to provide documentation of prior LD testing and/or related medicalrecords

  • 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 returneddespite 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 forat least 4 weeks prior to final determination of study eligibility and for theduration of the 12-week study.

  • Participant expresses willingness to not start new medications that might affecttreatment outcome during the trial (unless medically necessary), and willingness toinform study staff regarding any changes in medication

  • Live in the US or Canada and comfortable speaking English

  • Age 18-65

  • 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

Exclusion Criteria:

  • Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medicalillness over the last 12 months (e.g., cancer, acute myocardial infarction, labilehypertension) b. Any severe skin disorder or skin sensitive area near stimulationlocations (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

  • Post stroke deficits that may interfere with assessment

  • Any progressive neurodegenerative disorder or other neurological disorders that mayinterfere with assessment at discretion of the investigator.

Psychiatric: Any of the following:

  • History of intellectual disability, or other developmental neurological conditionassociated with cognitive impairment

  • Current primary psychiatric disorder that would interfere with ability toparticipate

  • 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 orillicit), or other medication considered likely to interfere with treatmentoutcome at the discretion of the investigator. The use of a stable dose ofbenzodiazepines, anticholinergic agents and non-narcotic pain medications ispermitted. The use of an occasional dose of these medications is alsopermitted, but not within 48 hours of neurocognitive study assessments.

  • Participants whose current daily medication regimen has not been stable for aminimum of 4 weeks prior to final determination of study eligibility

  • Medical device implanted in the head (such as a Deep Brain Stimulator) or inthe neck (such as a Vagus Nerve Stimulator), or metal implants in the head orneck

  • Inadequate visual or motor skills needed for regular computer use or to operatestudy 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 enhancingsupplements/medications or other therapies that might affect treatment outcome

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: Cognitive training
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Columbia University Department of Psychiatry

    New York, New York 10032
    United States

    Active - Recruiting

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