N/A
Completed N=54
Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
Healthy Volunteers
Source: ClinicalTrials.gov NCT03027414 ↗
Enrolled (actual)
54
Serious AEs
1.8%
Results posted
May 2022
Primary outcomePrimary: Anxiety-potentiated Startle — 6.032164105; 2.420193836; 3.412441384; 4.467812115 T-scores
Summary
Background:
Researchers want to better understand brain processes related to fear and anxiety. They want to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can reduce anxiety.
Objective:
To see how TMS affects fear and anxiety through memory and attention tasks.
Eligibility:
Healthy people ages 18-50 who are right-handed
Design:
Participants will be screened through another protocol.
Participants in the pilot study will have 1 visit. This includes:
Urine tests
Questionnaires about mood and thinking
Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud, sudden noises through headphones.
TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might receive fake TMS. This feels the same as real TMS. They will perform simple tasks. Participants in the main study will have 2 visits within 2 weeks.
The first visit includes:
Urine tests
Questionnaires about mood and thinking
MRI: Participants lie on a table that slides into a scanner. They will be in the scanner about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.
The second visit includes:
Shock and startle workup
TMS
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anxiety-potentiated Startle |
6.032164105; 2.420193836; 3.412441384; 4.467812115; 2.832028871; 4.960918182 | — |
| PRIMARY Working Memory (WM) Related Anxiety Downregulation While Performing the Sternberg WM Task Under Threat of Shock. |
— | — |
Eligibility Criteria
- INCLUSION CRITERIA:
- Ages 18-50
- Subjects able to give their consent
- Right handed
EXCLUSION CRITERIA
- Non-English speaking individual
- Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- Current or past Axis I psychiatric disorder(s) as identified with the Structured Clinical Interview for DSM-IV, non-patient edition (SCID-np)
- Active or history of active suicidal ideation.
- Evidence of a first-degree relative with history of psychosis or bipolar disorder; specifically, participant will know diagnosis or treatment in order to confirm presence of disorder.
- Alcohol/drug problems in the past year or lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV.
- Current use of medications that act on histamine (i.e. diphenhydramine), dopamine (methylphenidate), norepinephrine (buproprion), serotonin (sertraline), or acetylcholine (amitryptiline) receptors. Subjects will be excluded on this basis if they either 1) take these medications on a chronic basis, or 2) if they have taken the drug within 5 half-lives of the drug metabolism, determined by the medical professional at the time of screening.
- History of seizure (childhood febrile seizures are acceptable and these subjects may be included in the study),
- History of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (table below).
- Pregnancy, or positive pregnancy test.
- Neurological syndrome of the arm (e.g., carpal tunnel syndrome, cubital tunnel syndrome, etc.)
- Positive urine toxicology screen during the screening visit.
- IQ <80
- Employee or staff of NIMH or are an immediate family member of a NIMH employee, staff, or NIMH contractors.
- Allergy to lidocaine or topical anesthetics (participants in sub-study 3 only).
- Any medical condition that increases risk for fMRI or TMS:
- Any metal in their body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may small metal fragments in the eye.
- Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
- Patients who have difficulty lying flat on their back for up to 60 min in the scanner
- History of hearing loss
Data sourced from ClinicalTrials.gov (NCT03027414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.