Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
Columbia University
Study ID
NCT06915324
Status
Recruiting
Apply to this trial

Conditions

  • Post-Treatment Lyme Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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 — 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.

Study Details

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.

Key Dates

Start date
Jul 14, 2025
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Coding test scale score for acute treatment [ Time Frame: 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110
Piper Chase, BA
[email protected]
203-822-2116
Felicia Chow, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Department of PsychiatryNew YorkNew York10032
Alex Wetmore, BA
[email protected]
646-774-7503
Mara Kuvaldina, PhD
[email protected]
646-774-8108
Brian A Fallon, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAColumbia University Department of Psychiatry· New York, NY

Related Studies