Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

NCT02540616 | Withdrawn

• 1 other identifier: 2013-006-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mal de Debarquement Syndrome

Keywords

MdDS; TES; TMS

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory

  This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.

  10 years

Secondary Outcomes (2)

• Mal de Debarquement Balance Rating Scale

  10 years

• Hospital Anxiety and Depression Scale

  10 years

Other Outcomes (8)

• SF-12

  10 years

• Motion Sickness Susceptibility Scale

  10 years

• Neo-Five Factor Inventory

  10 years

Study Arms (2)

Transcranial Electrical Stimulation-Real

EXPERIMENTAL

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

Transcranial Electrical Stimulation-Sham

SHAM COMPARATOR

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

Interventions

Transcranial Electrical Stimulation DEVICE

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.

Also known as: Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS), Transcranial Random Noise Stimulation (tRNS), Sham Transcranial Stimulation

Transcranial Electrical Stimulation-Real; Transcranial Electrical Stimulation-Sham

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• Cha YH, Gleghorn D, Doudican BC. Double-blind randomized N-of-1 trial of transcranial alternating current stimulation for mal de debarquement syndrome. PLoS One. 2022 Feb 4;17(2):e0263558. doi: 10.1371/journal.pone.0263558. eCollection 2022.

  PMID: 35120184 DERIVED

MeSH Terms

Conditions

Mal de debarquement

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yoon-Hee Cha, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: September 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)