Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

NCT06915324 | Recruiting FDA Device

• 1 other identifier: AAAV1512
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Treatment Lyme Disease

Keywords

tDCS; Cognitive training; Neuromodulation; Brain Fog; Brain Stimulation; Lyme Disease; Chronic Lyme

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (9)

• Composite score of the reaction time measures

  4 weeks

• Fatigue Severity Scale (FSS) Score

  4 weeks

• General Symptom Questionnaire (GSQ-30) Score

  4 weeks

• Generalized Anxiety Disorder-7 (GAD-7) Score

  4 weeks

• PROMIS Emotional Distress-Depression-Short Form Score

  4 weeks

Study Arms (2)

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.

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.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive training

Interventions

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 training and active tDCS; Cognitive training and sham tDCS

Cognitive training 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 active tDCS; Cognitive training and sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 18-70
• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Columbia University: lead
• Steven & Alexandra Cohen Foundation: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

Columbia University Department of Psychiatry

New York, New York, 10032, United States

RECRUITING

Related Links

• Lyme Clinical Trials Network website
• Columbia Univ Medical Center Lyme tDCS Study
• UCSF Lyme tDCS Study

MeSH Terms

Conditions

Post-Lyme Disease Syndrome; Mental Fatigue; Lyme Disease

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brian A Fallon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Kuvaldina, PhD

CONTACT

646-774-8108; mk4480@cumc.columbia.edu

Ellen Brown, BA

CONTACT

646-774-7503; eb3048@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 8, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (2)