RECRUITING

Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

Conditions

Post-Treatment Lyme Disease tDCS Cognitive training Neuromodulation Brain Fog Brain Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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.

Official Title

Transcranial Direct Current Stimulation (tDCS) of Brain Fog in Patients With Post Treatment Lyme Disease

Quick Facts

Study Start:2025-06

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06915324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 18-65 * 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	* 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 may interfere with assessment at discretion of the investigator. * 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

Inclusion Criteria

Exclusion 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 18-65
* 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

* 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 may interfere with assessment at discretion of the investigator.
* 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

Contacts and Locations

Study Contact

Mara Kuvaldina, PhD

CONTACT

646-774-7503

mk4480@cumc.columbia.edu

Ellen Brown, BA

CONTACT

646-774-7503

eb3048@cumc.columbia.edu

Principal Investigator

Brian A Fallon, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Department of Psychiatry

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Brian A Fallon, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-06

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

tDCS
Cognitive training
Neuromodulation
Brain Fog
Brain Stimulation

Additional Relevant MeSH Terms

Post-Treatment Lyme Disease