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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
New York
Columbia University Department of Psychiatry
RECRUITING
New York
Contact Information
Primary
Mara Kuvaldina, PhD
mk4480@cumc.columbia.edu
646-774-8108
Backup
Ellen Brown, BA
eb3048@cumc.columbia.edu
646-774-7503
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2027-08
Participants
Target number of participants: 110
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Steven & Alexandra Cohen Foundation

This content was sourced from clinicaltrials.gov