Lyme Disease Patients With Memory Problems

Mass General Brigham

Status: Suspended

Conditions: Lyme Disease

Treatments: Device: Transcranial Direct Current Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT03500770

2015P000309

Details and patient eligibility

About

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.

Full description

Lyme disease is a tick-borne illness caused by Borrellia Bugdorferi after tick bite. This disease mostly presents with a skin rash which looks like bulls eye and therefore known as bulls-eye skin rash or Erythema Migrans. The standard of care of Lyme disease is a few weeks of antibiotics. Most of the patients do well after antibiotics treatment. However 10-20% of patients go on to develop persistent symptoms such as memory problems, fatigue and pain several months after the antibiotics treatment. Such symptoms are collectively known as Post Treatment Lyme Disease Syndrome. In this study we want to see if a device known as Transcranial Direct Current Stimulator (tDCS) is helpful in reducing these symptoms after Lyme disease treatment.

This study will consist of a total of 13 visits. After determining eligibility criteria through pre-screening and labs we will schedule visit 1. During visit 1 we will ask the study participants to fill several questionnaire forms related to memory, pain, fatigue, quality of life, depression and headache etc. We will draw blood to measure certain lab markers. We will do a few other tests to determine brain oxygenation level and to check brain waves.

During next 10 visits we will administer small current through a device known as Transcranial Direct Current Stimulator. This device and the amount of current delivered is very safe. Visit 12 is fairly the same as visit 1 as we will ask the study participant to answer questions related to memory, quality of life, pain, fatigue, depression and headache. During this visit we will also do the test to determine oxygenation level of brain and will perform brain wave testing.

Visit 13 will be last and final visit which will occur one month after visit 12. During this final visit the study participant will be asked to answer the questions related to memory, quality of life, pain, fatigue, depression and headache. During this visit we will again measure oxygenation level of brain and perform brain wave testing.

By doing this study in total 13 visits we expect to find out if the device "Transcranial Direct Current Stimulator" is helpful in reducing these symptoms after Lyme disease treatment.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Fifteen subjects will be selected to take part in this study. All subjects must meet the following criteria:

• Inclusion criteria:

  1. Age over 18 years, both males and females
  2. 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.
  3. Meet defining criteria of Post Treatment Lyme Disease Syndrome (PTLDS) proposed by Infectious Diseases Society of America (IDSA)
  4. Ability to give informed consent as assessed by study physician
  5. Willing to participate in 10 tDCS sessions over two week period
  6. 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:

  1. Evidence of any active Borrelia infection or co-infection such as Babesiois, Anaplasmosis, Erhlichiosis, Ricketsia as assessed by serum serology, such patient will be referred to ID

  2. Evidence of current or prior infection by B. Mioymoti or B. hemsii, such patients will be referred to ID

  3. Any of the exclusion criteria of Post Treatment Lyme Disease Syndrome (PTLDS) as proposed by Infectious Diseases Society of America (IDSA)

  4. History of other chronic inflammatory conditions such as:

     • Rheumatoid arthritis
     • Asthma
     • Autoimmune diseases
     • Chronic prostatitis
     • Glomerulonephritis
     • Celiac disease
     • Inflammatory bowel disease
     • Pelvic inflammatory disease
     • Interstitial cystitis
     • Vasculitis

  5. Existence of major neurologic or psychiatric condition such as epilepsy, severe depression or others

  6. Past history of neurosurgery

  7. History of significant alcohol or drug abuse during previous 6 months

  8. Presence of unstable medical conditions such as uncontrolled diabetes mellitus, cardiac pathology, cancer, kidney insufficiency, acute thrombosis or others

  9. Any new medication or dosage changes in the past 60 days interfering with your symptoms related to PTLDS

  10. Concurrent use of opioids or narcotics which cause CNS suppression, cognitive or motor slowing

  11. Concurrent use of muscle relaxants

  12. Concurrent use of anti-epileptics such as Carbamazepine

  13. Pregnancy as assessed by urine pregnancy test

  14. Contraindication to tDCS such as metal in the head or implanted electronic medical devices.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Transcranial Direct Current Stimulator

Experimental group

Description:

The Transcranial Direct Current Stimulator device (tDCS) is a safe technique which poses a non-significant risk to study subjects. This technique uses weak current which is applied by using two electrodes. In the literature, no undesirable or long-lasting side effects due to device have been reported, nor have any participants reportedly abandoned a study due to discomfort.

Treatment:

Device: Transcranial Direct Current Stimulator