Transcranial Direct Current Stimulation for Post Treatment Lyme Disease
ConditionPost-Treatment Lyme Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColumbia University
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
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
Treatments tested in this trial
- Transcranial Direct Current Stimulation (tDCS)
- Cognitive training
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
Steven & Alexandra Cohen Foundation
Collaborator
Source ClinicalTrials.gov