Phase
Condition
Lyme Disease
Rash
Treatment
Cognitive training
Transcranial Direct Current Stimulation (tDCS)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
History of diagnosis of Lyme disease by a health care provider, meeting criteria foreither definite or probable or possible LD
Willingness to provide documentation of prior LD testing and/or related medicalrecords
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 returneddespite 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 forat least 4 weeks prior to final determination of study eligibility and for theduration of the 12-week study.
Participant expresses willingness to not start new medications that might affecttreatment outcome during the trial (unless medically necessary), and willingness toinform 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
Exclusion
Exclusion Criteria:
- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medicalillness over the last 12 months (e.g., cancer, acute myocardial infarction, labilehypertension) b. Any severe skin disorder or skin sensitive area near stimulationlocations (e.g. forehead)
Neurologic: Any of the following:
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
Post stroke deficits that may interfere with assessment
Any progressive neurodegenerative disorder or other neurological disorders that mayinterfere with assessment at discretion of the investigator.
Psychiatric: Any of the following:
History of intellectual disability, or other developmental neurological conditionassociated with cognitive impairment
Current primary psychiatric disorder that would interfere with ability toparticipate
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
Currently taking opiate-based medications, dissociative drugs (prescribed orillicit), or other medication considered likely to interfere with treatmentoutcome at the discretion of the investigator. The use of a stable dose ofbenzodiazepines, anticholinergic agents and non-narcotic pain medications ispermitted. The use of an occasional dose of these medications is alsopermitted, but not within 48 hours of neurocognitive study assessments.
Participants whose current daily medication regimen has not been stable for aminimum of 4 weeks prior to final determination of study eligibility
Medical device implanted in the head (such as a Deep Brain Stimulator) or inthe neck (such as a Vagus Nerve Stimulator), or metal implants in the head orneck
Inadequate visual or motor skills needed for regular computer use or to operatestudy equipment, or inability to provide informed consent
Individuals who are pregnant or breastfeeding or planning to become pregnant
Lifestyle Considerations: Participants not willing to refrain from beginning,resuming or increasing non study cognitive training or cognitive enhancingsupplements/medications or other therapies that might affect treatment outcome
Study Design
Study Description
Connect with a study center
Columbia University Department of Psychiatry
New York, New York 10032
United StatesActive - Recruiting
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