Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorM.D. Anderson Cancer Center

About this trial

To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 21 to 60

BMI>30 (confirmed at in person visit)

Able to follow verbal and written instructions in English and complete all aspects of the study.

Have an address and telephone number where they may be reached.

Disqualifiers

rTMS exposure for treatment or research purposes in the last 6 months.

History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.

Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).

History of brain surgery, implanted electronic device, metal in the head.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    Device

    RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intermittent theta burst stimulationExperimental treatment 1 intervention
Group B: Continuous theta burst stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs).

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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