Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

NCT ID: NCT06915324

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2027-08-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cognitive training and active tDCS

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.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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 training

Intervention Type: BEHAVIORAL

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.

Cognitive training and sham tDCS

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.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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 training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

Cognitive training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven & Alexandra Cohen Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Brian A Fallon

Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian A Fallon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Columbia University Department of Psychiatry

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mara Kuvaldina, PhD

Role: CONTACT

mk4480@cumc.columbia.edu

646-774-8108

Ellen Brown, BA

Role: CONTACT

eb3048@cumc.columbia.edu

646-774-7503

Facility Contacts

Elana Farrell, BA

Role: primary

elana.farrell@ucsf.edu

415-476-5104

Alex Wetmore, BA

Role: primary

aw3661@cumc.columbia.edu

646-774-7503

Mara Kuvaldina, PhD

Role: backup

mk4480@cumc.columbia.edu

646-774-8108

Other Identifiers

AAAV1512

Identifier Type: -

Identifier Source: org_study_id

NCT06997341

Identifier Type: -

Identifier Source: nct_alias