Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Treatment of Insomnia (NCT NCT02196025)

NCT ID: NCT02196025

Last Updated: 2024-08-06

Results Overview

Change in Pittsburgh sleep quality index scores at the end of three weeks of stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: three weeks
• Results posted on: 2024-08-06

Participant Flow

Participants were only included in the study if they met all of the inclusion and no exclusion criteria. Participants must have had a primary diagnosis of insomnia in order to qualify.

Participant milestones

Measure	Transcranial Magnetic Stimulation Patients will receive sequential bilateral bifrontal low frequency Transcranial Magnetic Stimulation (TMS) daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept. Transcranial magnetic stimulation: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Overall Study STARTED	23
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Magnetic Stimulation for Treatment of Insomnia

Baseline characteristics by cohort

Measure	Transcranial Magnetic Stimulation n=19 Participants Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept. Transcranial magnetic stimulation: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: three weeks

Population: All participants who completed the PSQI at baseline through week 3

Change in Pittsburgh sleep quality index scores at the end of three weeks of stimulation with transcranial magnetic stimulation. Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)

Outcome measures

Measure	Transcranial Magnetic Stimulation n=20 Participants Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept. Transcranial magnetic stimulation: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Pittsburgh Sleep Quality Index ( PSQI) Baseline score	12.50 score on a scale Standard Deviation 2.74
Pittsburgh Sleep Quality Index ( PSQI) End of week 3	9.50 score on a scale Standard Deviation 4.27
Pittsburgh Sleep Quality Index ( PSQI) End of week 1	11.70 score on a scale Standard Deviation 3.73
Pittsburgh Sleep Quality Index ( PSQI) End of week 2	10.37 score on a scale Standard Deviation 4.04

SECONDARY outcome

Timeframe: three weeks

Population: All participants who completed the ISI from baseline to week 3

Change in insomnia severity index scores at the end of three weeks stimulation with transcranial magnetic stimulation. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

Outcome measures

Measure	Transcranial Magnetic Stimulation n=20 Participants Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept. Transcranial magnetic stimulation: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Insomnia Severity Index ( ISI) End of week 1	18.37 score on a scale Standard Deviation 5.49
Insomnia Severity Index ( ISI) Baseline	20.05 score on a scale Standard Deviation 5.14
Insomnia Severity Index ( ISI) End of week 2	13.94 score on a scale Standard Deviation 7.10
Insomnia Severity Index ( ISI) End of week 3	10.29 score on a scale Standard Deviation 7.74

Adverse Events

Transcranial Magnetic Stimulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Transcranial Magnetic Stimulation n=23 participants at risk Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept. Transcranial magnetic stimulation: Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
Eye disorders Slight right eye twinge	4.3% 1/23 • Number of events 1 • Adverse event data was captured from enrollment through the end of week 3 for each participant All adverse events (AE) are captured per CT.gov and University of Florida (UF) requirements. AE's are assessed at each visit.
Nervous system disorders Headache	4.3% 1/23 • Adverse event data was captured from enrollment through the end of week 3 for each participant All adverse events (AE) are captured per CT.gov and University of Florida (UF) requirements. AE's are assessed at each visit.
Skin and subcutaneous tissue disorders Pain at stimulation sight	4.3% 1/23 • Adverse event data was captured from enrollment through the end of week 3 for each participant All adverse events (AE) are captured per CT.gov and University of Florida (UF) requirements. AE's are assessed at each visit.

Additional Information

Robyn Nelson

University of Florida

Phone: 3522945563

Email: r.nelson@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place