Neurofeedback With Real-Time fMRI for Treatment of PTSD
| Status: | Suspended |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/20/2019 |
| Start Date: | January 2020 |
| End Date: | January 2021 |
Neurofeedback With Real-Time fMRI for Treatment of Posttraumatic Stress Disorder
PTSD is a debilitating and costly condition and currently available treatment options have
risks and limitations that necessitate development of novel interventions. Collectively, the
functional brain imaging reports suggest that patients with PTSD, especially those with the
re-experiencing and hypervigilence phenotype, show ventromedial PFC hypoactivation and
amygdala hyperactivation in response to symptom provocation, and that treatment, when
successful is associated with reduced amygdala and increased ventromedial PFC activation.
This project is guided by a neurocircuit model of PTSD dysfunction in which abnormalities in
fronto-limbic imbalance, which diminishes capacity for fear extinction learning, and produces
PTSD symptoms of re-experiencing and hyperarousal. Thus, our studies aim to bridge the
translational gap between theoretical and neurobiological models of PTSD to implementation of
clinical practice. The Target Engagement and Dosing Phase of this project, which is a pilot
study, will demonstrate target engagement and its association with laboratory measures of
PTSD-relevant neural processes.
risks and limitations that necessitate development of novel interventions. Collectively, the
functional brain imaging reports suggest that patients with PTSD, especially those with the
re-experiencing and hypervigilence phenotype, show ventromedial PFC hypoactivation and
amygdala hyperactivation in response to symptom provocation, and that treatment, when
successful is associated with reduced amygdala and increased ventromedial PFC activation.
This project is guided by a neurocircuit model of PTSD dysfunction in which abnormalities in
fronto-limbic imbalance, which diminishes capacity for fear extinction learning, and produces
PTSD symptoms of re-experiencing and hyperarousal. Thus, our studies aim to bridge the
translational gap between theoretical and neurobiological models of PTSD to implementation of
clinical practice. The Target Engagement and Dosing Phase of this project, which is a pilot
study, will demonstrate target engagement and its association with laboratory measures of
PTSD-relevant neural processes.
The proposed treatment is expected to reduce symptoms of PTSD particularly re-experiencing
and hyperarousal symptoms. These improvements in symptoms are expected to translate into
improved social and occupational function for subjects with PTSD.
Specific Aim 1: The investigators will test (1) the efficacy of neurofeedback in subjects
with PTSD attempting to upregulate ventral medial PFC and simultaneously downregulate
amygdala, and (2) determine the number of neurofeedback sessions (dose) needed for target
engagement and transfer. Prior to the neurofeedback training, participants' baseline ability
to regulate in the absence of neurofeedback from real-time fMRI will be ascertained. Then
during session, participants will receive veridical real-time feedback in the scanner
indicating the activation level of ventromedial PFC minus amygdala. Participants will attempt
to regulate to achieve a predetermined target level known to the participant. Neurofeedback
conditions will include (1) false feedback (sham) shows a thermometer that indicates false
feedback consisting of noise, (2) view condition shows a thermometer that indicates true
activation of ventromedial PFC minus amygdala but the participant is asked not to attempt
neuroregulation, (3) free regulate shows a thermometer that indicates true activation of
ventromedial PFC minus amygdala while the participant attempts neuroregulation. The
investigators will enroll 10 participants who will engage in a six weekly neurofeedback
sessions to assess target engagement and dosing.
Specific Aim 2: The ability for participants to regulate will be further challenged by
explicit exposure to trauma relevant stimuli that elicit increased amygdala activation in
patients with PTSD. The investigators will follow the same procedure as the previous aim
except that free regulate condition (condition #3) will be replaced with conditions (4)
trauma regulate shows a participant-specific trauma-relevant image and the thermometer that
indicates true activation of ventromedial PFC minus amygdala while the participant attempts
neuroregulation, and (5) neutral regulate shows a trauma-unrelated image and the thermometer
that indicates true activation of ventromedial PFC minus amygdala while the participant
attempts neuroregulation. The investigators will enroll 10 participants who will engage in a
six weekly neurofeedback sessions to assess target engagement and dosing.
Participants will be assessed for PTSD and related symptoms before and after to the 6-week
intervention using the Clinician Administered PTSD Scale (CAPS) (Appendix XVI) and Beck
Depression Inventory (BDI-II) (Appendix IX). The investigators hypothesize enhanced
neuroregulation and transfer will be associated with a concomitant reduction in PTSD severity
and lower comorbid anxiety symptoms.
Specific Aim 3: Participants will be assessed before and after the 6-week intervention with a
brief neurocognitive battery of episodic memory, working memory, executive function, and
sustained attention. The investigators hypothesize that successful neuroregulation and
transfer will be associated with concomitant cognitive performance improvements.
and hyperarousal symptoms. These improvements in symptoms are expected to translate into
improved social and occupational function for subjects with PTSD.
Specific Aim 1: The investigators will test (1) the efficacy of neurofeedback in subjects
with PTSD attempting to upregulate ventral medial PFC and simultaneously downregulate
amygdala, and (2) determine the number of neurofeedback sessions (dose) needed for target
engagement and transfer. Prior to the neurofeedback training, participants' baseline ability
to regulate in the absence of neurofeedback from real-time fMRI will be ascertained. Then
during session, participants will receive veridical real-time feedback in the scanner
indicating the activation level of ventromedial PFC minus amygdala. Participants will attempt
to regulate to achieve a predetermined target level known to the participant. Neurofeedback
conditions will include (1) false feedback (sham) shows a thermometer that indicates false
feedback consisting of noise, (2) view condition shows a thermometer that indicates true
activation of ventromedial PFC minus amygdala but the participant is asked not to attempt
neuroregulation, (3) free regulate shows a thermometer that indicates true activation of
ventromedial PFC minus amygdala while the participant attempts neuroregulation. The
investigators will enroll 10 participants who will engage in a six weekly neurofeedback
sessions to assess target engagement and dosing.
Specific Aim 2: The ability for participants to regulate will be further challenged by
explicit exposure to trauma relevant stimuli that elicit increased amygdala activation in
patients with PTSD. The investigators will follow the same procedure as the previous aim
except that free regulate condition (condition #3) will be replaced with conditions (4)
trauma regulate shows a participant-specific trauma-relevant image and the thermometer that
indicates true activation of ventromedial PFC minus amygdala while the participant attempts
neuroregulation, and (5) neutral regulate shows a trauma-unrelated image and the thermometer
that indicates true activation of ventromedial PFC minus amygdala while the participant
attempts neuroregulation. The investigators will enroll 10 participants who will engage in a
six weekly neurofeedback sessions to assess target engagement and dosing.
Participants will be assessed for PTSD and related symptoms before and after to the 6-week
intervention using the Clinician Administered PTSD Scale (CAPS) (Appendix XVI) and Beck
Depression Inventory (BDI-II) (Appendix IX). The investigators hypothesize enhanced
neuroregulation and transfer will be associated with a concomitant reduction in PTSD severity
and lower comorbid anxiety symptoms.
Specific Aim 3: Participants will be assessed before and after the 6-week intervention with a
brief neurocognitive battery of episodic memory, working memory, executive function, and
sustained attention. The investigators hypothesize that successful neuroregulation and
transfer will be associated with concomitant cognitive performance improvements.
Inclusion Criteria:
- Fluent in English and capable of informed consent
- free of implanted metal objects
- 18-50 years of age
- Antidepressant sleep and anti-anxiety medication use is permitted
Exclusion Criteria:
- Claustrophobia
- Neurological disorders, History of learning disability or developmental delay
- Current substance abuse or history of substance dependence
- Psychotic disorders
- Significant medical conditions
- Current suicidality or attempt within the previous year
- History of neurological injury or disease
- Pregnancy
- Major Axis 1 Psychiatric Disorders (exceptions are unipolar depression, past substance
abuse, current or past nicotine dependence)
- Metal in the body
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Rajendra A Morey, MD
Phone: 919-384-8582
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
