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New treatment option for Post-Treatment Lyme Disease
Official title Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
ClinicalTrials.gov ID: NCT06915324
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
- Current cognitive symptoms interfere with function and/or cause distress
You likely can't join if
- \- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medical illness over the last 12 months (e.g., cancer, acute...
- 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
See the full eligibility criteria
Who can join
- 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
- 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 for at least 4 weeks prior to final determination of study eligibility and for the duration of the 12-week study.
- Participant expresses willingness to not start new medications that might affect treatment outcome during the trial (unless medically necessary), and willingness to inform study staff regarding any changes in medication
- Live in the US or Canada and comfortable speaking English
- Age 18-70
- 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
What rules you out
- \- 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...
- 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 may interfere with assessment at discretion of the investigator. 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
- Currently taking opiate-based medications, dissociative drugs (prescribed or illicit), or other medication considered likely to interfere with treatment outcome at the discretion of the investigator. The use of a stable...
- Participants whose current daily medication regimen has not been stable for a minimum of 4 weeks prior to final determination of study eligibility
- Medical device implanted in the head (such as a Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator), or metal implants in the head or neck
- Inadequate visual or motor skills needed for regular computer use or to operate study 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 enhancing supplements/medications or other therapies that might affect...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.