About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Cognitive training and active tDCSExperimental treatment 2 interventions

Group B: Cognitive training and sham tDCSSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

4 weeks

2

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.

Time frame

12 weeks

Secondary outcomes

1

Composite score of the reaction time measures

Composite score of the reaction time measures (Coding, Choice Reaction Time, Grooved Pegboard, and the Test of Silent Word Reading Fluency-2), measured in Z-scores from -4 to +4 with a higher score representing a better outcome.

Time frame

4 weeks

2

Fatigue Severity Scale (FSS) Score

This is a self-reported measure of fatigue. This measure consists of 9 items inquiring about the severity of fatigue in different situations over the past week. Scores for each item range from 1 to 7 where 1 indicates strong disagreement and 7 strong agreements. Higher scores indicate higher levels of fatigue.

Time frame

4 weeks

3

General Symptom Questionnaire (GSQ-30) Score

This is a 30 item self-reported measure of symptom burden. The measure asks participants to rate how bothered they have been with a particular symptom over a 2-week time frame. The total score ranges from 0 to 120 with higher score indicating higher symptom severity.

Time frame

4 weeks

4

Generalized Anxiety Disorder-7 (GAD-7) Score

This is a measure of severity of anxiety. It has 7 seven items, and the scores range from 0 to 21 with higher scores indicating more pronounced anxiety.

Time frame

4 weeks

Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts