Brain Stimulation + Cognitive Training for Lyme Disease

Overseen By Elana Farrell, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Opiates, Dissociatives, others

Disqualifiers: Cancer, Seizure, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 4 weeks

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Felicia C Chow, MD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals who have cognitive symptoms after being treated for Lyme disease, known as Post Treatment Lyme Disease (PTLD). Participants will engage in at-home cognitive training with either real or sham brain stimulation over a period of 4 weeks.

Inclusion Criteria

Adequate home facilities (enough space, access to quiet and distraction-free area)

Stable and continuous access to internet service

Willingness to provide documentation of prior LD testing and/or related medical records

Exclusion Criteria

I have long-lasting symptoms from a past brain injury.

I haven't had any unstable chronic illnesses like cancer or heart issues in the past year.

I have severe skin issues or sensitivity where a device would be placed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcranial direct current stimulation (tDCS) combined with computer-based cognitive training at home for 4 weeks

4 weeks

20 sessions (at home)

Follow-up

Participants are monitored for sustained treatment benefits in processing speed and other cognitive functions

8 weeks

Treatment Details

Interventions

• Cognitive training
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if transcranial direct current stimulation (tDCS), paired with cognitive training games, can improve processing speed in PTLD patients. It compares the effects of active and sham stimulation to see if any improvements last 8 weeks post-treatment.

Participant Groups

Group I: Cognitive training and active tDCS Experimental Treatment 2 Interventions

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 II: Cognitive training and sham tDCS Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Bay Area Lyme Foundation

Collaborator