SuspendedNot Applicable

Lyme Disease Patients With Memory Problems

Stopped: lack of funding

United States15 participantsStarted 2019-02-20

Plain-language summary

The main purpose of this study is to see if a device known as Transcranial Direct Current Stimulator (tDCS) is helpful in reducing persistent symptoms after Lyme disease treatment. Some of these symptoms include problems with memory, fatigue or pain.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age over 18 years, both males and females
. History of Lyme disease as diagnosed per CDC criteria and/or evidence of Erythema Migrans or diagnosis of Lyme disease as documented in medical record by an experienced health care practitioner.
. Meet defining criteria of Post Treatment Lyme Disease Syndrome (PTLDS) proposed by Infectious Diseases Society of America (IDSA)
. Ability to give informed consent as assessed by study physician
. Willing to participate in 10 tDCS sessions over two week period
. If on long-term antibiotics or supplements for treatment of Lyme disease must be willing to keep treatment regimen consistent during participation in the study

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cognitive dysfunction

Timeframe: up to 12 weeks

Trial details

NCT IDNCT03500770

SponsorSpaulding Rehabilitation Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-30

View on ClinicalTrials.gov More Lyme Disease trials