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| Name | Class |
|---|---|
| Steven & Alexandra Cohen Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive training and active tDCS | Experimental | 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. |
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| Cognitive training and sham tDCS | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Fatigue Severity Scale (FSS) Score |
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Inclusion Criteria:
Exclusion Criteria:
- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medical illness over the last 12 months (e.g., cancer, acute myocardial infarction, labile hypertension) b. Any severe skin disorder or skin sensitive area near stimulation locations (e.g. forehead)
Neurologic: Any of the following:
Psychiatric: Any of the following:
History of intellectual disability, or other developmental neurological condition associated with cognitive impairment
Current primary psychiatric disorder that would interfere with ability to participate
Current alcohol or other substance use disorder
Current suicide risk as assessed by the C-SSRS (any level)
History of suicidal behavior over the last year
History of a diagnosis of a psychotic disorder, mania or bipolar disorder
Depression rating of moderate or severe at screening
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mara Kuvaldina, PhD | Contact | 646-774-8108 | mk4480@cumc.columbia.edu | |
| Ellen Brown, BA | Contact | 646-774-7503 | eb3048@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian A Fallon, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94110 | United States |
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| Label | URL |
|---|---|
| Lyme Clinical Trials Network website | View source |
| Columbia Univ Medical Center Lyme tDCS Study | View source |
| UCSF Lyme tDCS Study |
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| ID | Term |
|---|---|
| D000077342 | Post-Lyme Disease Syndrome |
| D005222 | Mental Fatigue |
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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All participants receive computer-based cognitive exercises to improve processing speed. During the cognitive exercises, half of the participants receive concomitant active tDCS while the other half of the participants receive concomitant sham tDCS.
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| 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. |
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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. |
| 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| PROMIS Emotional Distress-Depression-Short Form Score | This is a self-reported measure that assesses symptoms of depression during the past 7 days. It has 8 items. Each item ranges from 1 (never) to 5 (always) with higher scores representing more pronounced depression. | 4 weeks |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) symptom summary score | The PROMIS-29 is a 29 item self-report measure covering 7 symptom domains. The questions are ranked on a 5-point Likert Scale. The PROMIS-29 SPADE score represents the average T-score across the 5 SPADE (sleep disturbance, pain, anxiety, depression, and low energy/fatigue) domains with higher scores indicating greater symptom severity. The SPADE T-score ranges from 20-80 with higher scores indicating more symptom severity. | 4 weeks |
| Cognitive functioning z-score | Measures that include domains of cognitive function that are affected by processing speed (attention, memory, working memory and language fluency). Each measure has a raw score that is converted to z-score that ranges from -4 to +4 with higher score representing a better outcome. | 4 weeks |
| Neuro-QoL Short Form v1.0 - Applied Cognition Score | This is a self-reported measure that assesses cognitive function across neurological conditions. Items are scored on a 5-point scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. Raw scores are converted based on consistent metric (T-distribution) with data from the US general population with a T-score mean of 50 and standard deviation of 10. Higher score indicates a greater degree of reported cognitive difficulties. | 4 weeks |
| Brain Fog Visual Analogue Scale (Brain Fog VAS) Score | This is self-reported measure of cognitive complaints severity (brain fog). It measures the period over the last 7 days, score ranges from 0 to 10 with higher score indicating a higher severity of reported brain fog. | 4 weeks |
| Columbia University Department of Psychiatry | Recruiting | New York | New York | 10032 | United States |
|
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |