NCT06931236

Brief Summary

To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 30, 2025

Last Update Submit

April 9, 2025

Conditions

Generalized Anxiety Disorder (GAD)InsomniaRepetitive Transcranial Magnetic Stimulation (rTMS)

Keywords

generalized anxiety disorderinsomniaRepetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

  • subjective sleep quality assessed by the PSQI

    The Pittsburgh Sleep Quality Index (PSQI) consist of 18 items divided into 7 dimensions, such as sleep duration, sleep efficiency, sleep disorders and daytime dysfunction. The PSQI total score ranges from 0 to 21, the higher the score indicates the more worse sleep quality.

    before and after 10-day intervention and at 1-month follow-up

  • subjective sleep quality assessed by the ISI

    The Insomnia Severity Index (ISI) is a 7-item scale to measure insomnia symptoms, where each item is rated on a scale from 0 to 4. The ISI total score ranges from 0 to 28, The higher the score indicates the more worse sleep quality.

    before and after 10-day intervention and at 1-month follow-up

  • emotional symptoms assessed by the HAMA

    The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.

    before and after 10-day intervention and at 1-month follow-up

Secondary Outcomes (1)

  • emotional symptoms assessed by the HAMD

    before and after 10-day intervention and at 1-month follow-up

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT).

Device: Repetitive Transcranial Magnetic Stimulation

sham stimulation

SHAM COMPARATOR

sham rTMS is carried out as the coil is turned away from the skull at 90°.

Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses.

real stimulation
Sham Repetitive Transcranial Magnetic StimulationDEVICE

Sham tDCS was delivered using the same protocol and current intensity, but it is carried out as the coil is turned away from the skull at 90°.

sham stimulation

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age between 15 and 65 years;
  • clinically diagnosed with anxiety according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V);
  • no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

You may not qualify if:

  • current or history of serious brain and body diseases;
  • current or history of schizophrenia, behavioral problems, post-traumatic stress disorder, mania, obsessive-compulsive disorder, and social phobia;
  • substance abuse or other comorbid psychological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderSleep Initiation and Maintenance Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice President of Anhui Medical University

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 17, 2025

Study Start

August 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 17, 2025

Record last verified: 2025-03

Locations

CN(1)