Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

Mal de Debarquement Syndrome Clinical Trial

Official title:

Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02540616
• Other study ID #: 2013-006-01
• Status: Withdrawn
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2022

Study information

• Verified date: March 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mal de Debarquement Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SF-12	Well established Quality of Life Scale	10 years
Other	Motion Sickness Susceptibility Scale	Measures motion sickness susceptibility before and after age 12	10 years
Other	Neo-Five Factor Inventory	Quantifies the five major personality traits	10 years
Other	Empathy Quotient	40 item online or 20 item abbreviated scale to determine strength of empathic traits	10 years
Other	Functional Activities Scale	Measures comfort with doing some basic activities of daily living	10 years
Other	Memory Questionnaire	Measures subjective impressions of prospective and retrospective memory	10 years
Other	Multidimensional Fatigue Inventory	Measures general, physical, and mental fatigue	10 years
Other	Edinburgh Handedness Scale	Standard measure of handedness	10 years
Primary	Dizziness Handicap Inventory	This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.	10 years
Secondary	Mal de Debarquement Balance Rating Scale	This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function.	10 years
Secondary	Hospital Anxiety and Depression Scale	This is a well validated 42 point self-reported scale of anxiety and dizziness.	10 years