Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

NCT ID: NCT02540616

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Mal de Debarquement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Electrical Stimulation

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Transcranial Electrical Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Transcranial Direct Current Stimulation (tDCS); Transcranial Alternating Current Stimulation (tACS); Transcranial Random Noise Stimulation (tRNS); Sham Transcranial Stimulation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoon-Hee Cha, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35120184 (View on PubMed)

Other Identifiers

2013-006-01

Identifier Type: -

Identifier Source: org_study_id