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Trial Outcomes & Findings for Impact of Theta Burst Stimulation Over the Left DLPFC on Language Switching (NCT NCT03148470)

NCT ID: NCT03148470

Last Updated: 2020-04-22

Results Overview

Picture naming with the factors Language (L1, L2) and Block (Switching, Non-Switching): Speech onset times (msec) L1 refers to the mother tongue. L2 refers to the late acquired (\> age 7) second language. Switching Block refers to a language switching block with picture naming alternated between the mother tongue and the second language. Non-Switching Block refers to a block of picture naming either only in the mother or only in the second language.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

Within 30 minutes after intervention

Results posted on

2020-04-22

Participant Flow

Participant milestones

Participant milestones
Measure
iTBS Group
intermittent theta burst stimulation (iTBS) + Sham iTBS * Sham iTBS: Placebo stimulation (3 Min) * Tasks (30 Min) * Pause (10Min) * iTBS: Excitatory stimulation (3Min) * Tasks (30Min)
cTBS Group
continuous theta burst stimulation (cTBS) + Sham cTBS * Sham cTBS: Placebo stimulation (40Sec) * Tasks (30min) * Pause (10Min) * cTBS: inhibitory stimulation (40 Sec) * Tasks (30Min)
Overall Study
STARTED
21
20
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intermittent Theta Burst Stimulation
n=21 Participants
intermittent theta burst stimulation (iTBS) + Sham iTBS Sham iTBS: Placebo stimulation intermittent theta burst stimulation (iTBS): Excitatory rTMS
Continuous Theta Burst Stimulation
n=20 Participants
continuous theta burst stimulation (cTBS) + Sham cTBS Sham cTBS: Placebo stimulation continuous theta burst stimulation (cTBS): inhibitory rTMS
Total
n=41 Participants
Total of all reporting groups
Age, Continuous
22.1 years
STANDARD_DEVIATION 2.7 • n=21 Participants
22.8 years
STANDARD_DEVIATION 5.36 • n=20 Participants
22.4 years
STANDARD_DEVIATION 4.2 • n=41 Participants
Sex: Female, Male
Female
15 Participants
n=21 Participants
16 Participants
n=20 Participants
31 Participants
n=41 Participants
Sex: Female, Male
Male
6 Participants
n=21 Participants
4 Participants
n=20 Participants
10 Participants
n=41 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Switzerland
21 participants
n=21 Participants
20 participants
n=20 Participants
41 participants
n=41 Participants

PRIMARY outcome

Timeframe: Within 30 minutes after intervention

Population: As a primary outcome we compared RTs following iTBS vs cTBS. Sham-TBS is only used to have a baseline control between the two groups

Picture naming with the factors Language (L1, L2) and Block (Switching, Non-Switching): Speech onset times (msec) L1 refers to the mother tongue. L2 refers to the late acquired (\> age 7) second language. Switching Block refers to a language switching block with picture naming alternated between the mother tongue and the second language. Non-Switching Block refers to a block of picture naming either only in the mother or only in the second language.

Outcome measures

Outcome measures
Measure
RTs for Picture Naming in the Non-switching Blocks
n=40 Participants
Voice onset times for Picture Naming in the non-switching blocks - across L1 and L2 and across iTBS and cTBS.
RTs for PN After Intermittent Theta Burst Stimulation
n=20 Participants
intermittent theta burst stimulation (iTBS) - across switching and non-switching blocks and across L1 and L2.
RTs for PN After Continuous Theta Burst Stimulation
n=20 Participants
continuous theta burst stimulation (cTBS) - across switching and non-switching blocks and across L1 and L2.
RTs for Picture Naming in L1
n=40 Participants
Voice onset times for Picture Naming in L1 - across switching and non-switching blocks and across iTBS and cTBS.
RTs for Picture Naming in L2
n=40 Participants
Voice onset times for Picture Naming in L2 - across switching and non-switching blocks and across iTBS and cTBS.
RTs for Picture Naming in the Switching Blocks
n=40 Participants
Voice onset times for Picture Naming in the switching blocks - across L1 and L2 and across iTBS and cTBS.
RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching)
1081.14 Milliseconds
Standard Deviation 414
1103.32 Milliseconds
Standard Deviation 126
1107.26 Milliseconds
Standard Deviation 131
1098.82 Milliseconds
Standard Deviation 405
1158.91 Milliseconds
Standard Deviation 432
1175.24 Milliseconds
Standard Deviation 420

SECONDARY outcome

Timeframe: Within 30 minutes after intervention

Population: Data are compared between iTBS and cTBS Sham-TBS is only used to have a baseline control between the two groups

Nonverbal Switching: response times

Outcome measures

Outcome measures
Measure
RTs for Picture Naming in the Non-switching Blocks
Voice onset times for Picture Naming in the non-switching blocks - across L1 and L2 and across iTBS and cTBS.
RTs for PN After Intermittent Theta Burst Stimulation
n=20 Participants
intermittent theta burst stimulation (iTBS) - across switching and non-switching blocks and across L1 and L2.
RTs for PN After Continuous Theta Burst Stimulation
n=20 Participants
continuous theta burst stimulation (cTBS) - across switching and non-switching blocks and across L1 and L2.
RTs for Picture Naming in L1
Voice onset times for Picture Naming in L1 - across switching and non-switching blocks and across iTBS and cTBS.
RTs for Picture Naming in L2
Voice onset times for Picture Naming in L2 - across switching and non-switching blocks and across iTBS and cTBS.
RTs for Picture Naming in the Switching Blocks
Voice onset times for Picture Naming in the switching blocks - across L1 and L2 and across iTBS and cTBS.
Nonverbal Switching
—
772.07 Milliseconds
Standard Deviation 159.28
739.32 Milliseconds
Standard Deviation 137.23
—
—
—

Adverse Events

cTBS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

iTBS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham iTBS

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Sham cTBS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
cTBS
n=20 participants at risk
continuous theta burst stimulation (cTBS)
iTBS
n=20 participants at risk
intermittent theta burst stimulation (iTBS)
Sham iTBS
n=21 participants at risk
Placebo (baseline) stimulation for iTBS group
Sham cTBS
n=20 participants at risk
Placebo (baseline) stimulation for cTBS group
Cardiac disorders
Nausea
0.00%
0/20 • 3 hours
0.00%
0/20 • 3 hours
4.8%
1/21 • Number of events 1 • 3 hours
0.00%
0/20 • 3 hours

Additional Information

Prof. Dr. Jean-Marie Annoni

University of Fribourg

Phone: ++4126 306 3802

Results disclosure agreements

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