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Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

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: NCT02540616
Recruitment Status : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Yoon-Hee Cha, University of Minnesota

Brief Summary:

The goal of this study is to determine whether external neuromodulation using transcranial electrical stimulation (TES) can reduce the perception of self-motion that is experienced by patients with MdDS. Mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. A similar form of rocking dizziness can be experienced without a motion trigger in individuals with certain risk factors.

Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic stimulation. The investigators will determine the optimal treatment duration and stimulation parameters.


Condition or disease Intervention/treatment Phase
Mal de Debarquement Syndrome Device: Transcranial Electrical Stimulation Not Applicable

Detailed Description:

Eligible participants who meet study criteria and pass the safety screen will be invited to participate in the study. If TES is used as add-on treatment to repetitive transcranial magnetic stimulation (rTMS), the training for TES application will be done on-site. However, in a portion of the study that does not involve rTMS, remote training will be performed via a webcam provided that a suitable "Study Buddy" is available to assist the participant.

Participants will maintain web-based diaries of their symptoms for up to four weeks prior to treatment with TES. Before the actual treatment sessions are started, the subjects will complete baseline questionnaires online which will be repeated once a week for up to 12 weeks. Over the course of the study, the subjects will also keep a daily log of their sessions such as how many sessions they performed, for how long, and whether they had any side effects with each session.

The studies will include a sham arm, allocated at a ratio of 1:1. On-site studies will involve the application of EEG, MRI, balance, cognitive, and visual/auditory stimulation tests.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcranial Electrical Stimulation for Mal de Debarquement Syndrome
Study Start Date : September 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcranial Electrical Stimulation-Real
The participant will perform real TES. The forms of TES used in this study will include transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or transcranial random noise stimulation (tRNS). Each stimulation session will last for 20-minutes.
Device: Transcranial Electrical Stimulation
A form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators.
Other Names:
  • Transcranial Direct Current Stimulation (tDCS)
  • Transcranial Alternating Current Stimulation (tACS)
  • Transcranial Random Noise Stimulation (tRNS)
  • Sham Transcranial Stimulation

Sham Comparator: Transcranial Electrical Stimulation-Sham
The participant will perform sham TES for 20-minutes. The form of sham TES will depend on the active arm, e.g. if tACS is on the active arm, then the sham tACS will be a different frequency of stimulation. If tDCS is the active arm, then a short ramp up of tDCS followed by a ramp down (about 60-seconds) will be used as the sham arm.
Device: Transcranial Electrical Stimulation
A form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators.
Other Names:
  • Transcranial Direct Current Stimulation (tDCS)
  • Transcranial Alternating Current Stimulation (tACS)
  • Transcranial Random Noise Stimulation (tRNS)
  • Sham Transcranial Stimulation




Primary Outcome Measures :
  1. Dizziness Handicap Inventory [ Time Frame: 10 years ]
    This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.


Secondary Outcome Measures :
  1. Mal de Debarquement Balance Rating Scale [ Time Frame: 10 years ]
    This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function.

  2. Hospital Anxiety and Depression Scale [ Time Frame: 10 years ]
    This is a well validated 42 point self-reported scale of anxiety and dizziness.


Other Outcome Measures:
  1. SF-12 [ Time Frame: 10 years ]
    Well established Quality of Life Scale

  2. Motion Sickness Susceptibility Scale [ Time Frame: 10 years ]
    Measures motion sickness susceptibility before and after age 12

  3. Neo-Five Factor Inventory [ Time Frame: 10 years ]
    Quantifies the five major personality traits

  4. Empathy Quotient [ Time Frame: 10 years ]
    40 item online or 20 item abbreviated scale to determine strength of empathic traits

  5. Functional Activities Scale [ Time Frame: 10 years ]
    Measures comfort with doing some basic activities of daily living

  6. Memory Questionnaire [ Time Frame: 10 years ]
    Measures subjective impressions of prospective and retrospective memory

  7. Multidimensional Fatigue Inventory [ Time Frame: 10 years ]
    Measures general, physical, and mental fatigue

  8. Edinburgh Handedness Scale [ Time Frame: 10 years ]
    Standard measure of handedness



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.


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

Inclusion Criteria:

  1. Age ≥18 years old
  2. Willing and capable of interacting with the informed consent process
  3. Primary disorder being a persistent perception of motion with no other cause determined after a careful interview.
  4. Able to identity a study buddy and provide contact information

Exclusion Criteria:

  1. Subjects who cannot comply with study conditions.
  2. Active psychiatric condition such as mania or psychosis
  3. Unstable medical condition
  4. Implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). Dental fillings are acceptable.
  5. Any active skin disorder that affects skin integrity of the scalp.
  6. Pregnant

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): NCT02540616


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
Investigators
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Principal Investigator: Yoon-Hee Cha, MD University of Minnesota
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Responsible Party: Yoon-Hee Cha, Yoon-Hee Cha, MD, University of Minnesota
ClinicalTrials.gov Identifier: NCT02540616    
Other Study ID Numbers: 2013-006-01
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized data will be shared once recruitment is sufficient to prevent the inadvertent identification of participants by demographic or clinical characteristics
Keywords provided by Yoon-Hee Cha, University of Minnesota:
MdDS
TES
TMS
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes