Lyme Disease Patients With Memory Problems

NCT03500770 | Suspended FDA Device

• 1 other identifier: 2015P000309
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Disease

Keywords

Post Treatment Lyme Disease Syndrome

Outcome Measures

Primary Outcomes (1)

• cognitive dysfunction

  CVLT test change from baseline

  up to 12 weeks

Secondary Outcomes (1)

• Fatigue

  up to 12 weeks

Other Outcomes (1)

• Pain

  up to 12 weeks

Study Arms (1)

Transcranial Direct Current Stimulator

EXPERIMENTAL

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

Interventions

Transcranial Direct Current Stimulator DEVICE

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.

Transcranial Direct Current Stimulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Evidence of current or prior infection by B. Mioymoti or B. hemsii, such patients will be referred to ID
• 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
• Existence of major neurologic or psychiatric condition such as epilepsy, severe depression or others
• Past history of neurosurgery

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Nevena Zubcevik

Cambridge, Massachusetts, 02140, United States

Location

MeSH Terms

Conditions

Lyme Disease; Post-Lyme Disease Syndrome

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nevena Zubcevik, DO

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physcian/Instructor, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: April 18, 2018
• Study Start: February 20, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)