Transcranial Electrical Stimulation for Mal de Debarquement Syndrome
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | September 2013 |
| End Date: | December 2022 |
| Contact: | Diamond Urbano, BA |
| Email: | mddsresearch@laureateinstitute.org |
| Phone: | 918-502-5127 |
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.
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.
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.
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.
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
We found this trial at
1
site
Tulsa, Oklahoma 74136
Principal Investigator: Yoon-Hee Cha, MD
Phone: 918-502-5126
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