NCT06915324

Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-07-14
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-04-08
• Last updated: 2025-07-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study