rTMS Intervention on Motivational Anhedonia of Treatment Resistant Depression and Brian Network Mechanism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-12-31

Brief Summary

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Study of individualized accurate targeting rTMS intervention on motivational anhedonia of treatment resistant depression and brain network mechanism

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Detailed Description

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Before treatment, Magnetic resonance images of each participant were acquired from scanner of the same type (3.0T, Discovery GE750w). As the key role of nucleus accumbens (NACC, -7.5, 5.5, 9) in anhedonia, the accurate target of left dlPFC was defined as the strongest functional connectivity with NACC. Each treatment session was under neuronavigation with a Visor neuronavigation system (ANT Neuro, Enschede, Netherlands) for coil positioning.

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to real group or sham group by coin toss. A threshold of 3 points on the Hamilton Depression scale has been specified by the National Institute for Health and Care Excellence to determine a clinically meaningful difference between active pharmacotherapy and placebo. We plan to enroll minimum total sample size of 29 participants in real and sham group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. The participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to the allocated condition and allocation parameters. Only the rTMS administrators had access to the randomization list. They had minimal contact with the patients, and no role in assessing depression. Each patient would be treated for continuous 15 days by rTMS.

Before the rTMS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale. The neuroimaging data was collected using functional magnetic resonance imaging scan in multimodalities, resting electroencephalography, and event-related potentials during monetary incentive delay task, and Iowa-gambling test. The participants had also received a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems). After the last treatment, the same scales and neuroimaging scan were used again to assess the treatment effect of the rTMS and the underlying brain mechanism. Each participant was interviewed in detail about the adverse event of the rTMS intervention during the past 15 days. A month after the last treatment, each participant received follow-up visit by telephone to access the persistent effect of the intervention. Every participant should take part in the study in voluntary and sign an informed consent form before the study.

Conditions

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Treatment Resistant Depression Transcranial Magnetic Stimulation Functional Magnetic Resonance Imaging Event-Related Potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Real Stimulation

The Real Stimulation of rTMS lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold (RMT) . Behavior and MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

Group Type ACTIVE_COMPARATOR

repeated transcranial magnetic stimulation with real coil

Intervention Type DEVICE

repeated transcranial magnetic stimulation with real coil is a noninvasive technique to activate and modify the activity of the neurons

Sham Stimulation

The procedure of Sham Stimulation protocol was performed by a placebo coil,lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

Group Type SHAM_COMPARATOR

repeated transcranial magnetic stimulation with sham coil

Intervention Type DEVICE

repeated transcranial magnetic stimulation with sham coil is a placebo

Interventions

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repeated transcranial magnetic stimulation with real coil

repeated transcranial magnetic stimulation with real coil is a noninvasive technique to activate and modify the activity of the neurons

Intervention Type DEVICE

repeated transcranial magnetic stimulation with sham coil

repeated transcranial magnetic stimulation with sham coil is a placebo

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

1. History of significant head trauma or neurological disorders.
2. Alcohol or drug abuse.
3. Focal brain lesions.
4. History of seizure.
5. First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
6. Significant unstable medical condition.
7. Recent aggression or other forms of behavioral dyscontrol.
8. Left-handedness.
9. Pregnancy.
10. Current alcohol or drug abuse
11. Inability to provide informed consent.
12. Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No