ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 30 for:    lyme AND Skin

Lyme Disease Patients With Memory Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03500770
Recruitment Status : Suspended (lack of funding)
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Nevena Zubcevik, Spaulding Rehabilitation Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Lyme Disease Device: Transcranial Direct Current Stimulator Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Transcranial Direct Current Stimulation (tDCS) for Cognitive Deficit, Fatigue and Pain in Patients With Post Treatment Lyme Disease Syndrome
Estimated Study Start Date : February 20, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulator
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.
Device: Transcranial Direct Current Stimulator
The tDCS device to be used will be an investigational, battery powered, custom-made stimulator able to deliver a biphasic alternate current. Active stimulation consists of 10 active tDCS sessions with current intensity fixed at 2mA for 20 minutes. It has been safely used in several other research studies. The side effects profile for this type of stimulation include tingling/itching at the site of stimulation, skin irritation/redness at the site of stimulation, headache or dizziness.




Primary Outcome Measures :
  1. cognitive dysfunction [ Time Frame: up to 12 weeks ]
    CVLT test change from baseline


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: up to 12 weeks ]
    GSQ Questionnaire change from baseline


Other Outcome Measures:
  1. Pain [ Time Frame: up to 12 weeks ]
    Analog scale pain level change from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500770


Locations
United States, Massachusetts
Nevena Zubcevik
Cambridge, Massachusetts, United States, 02140
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Nevena Zubcevik, DO Spaulding Rehabilitation Hospital

Responsible Party: Nevena Zubcevik, Attending Physcian/Instructor, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03500770     History of Changes
Other Study ID Numbers: 2015P000309
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Nevena Zubcevik, Spaulding Rehabilitation Hospital:
Post Treatment Lyme Disease Syndrome

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections