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Trial Outcomes & Findings for Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Alcoholism (NCT NCT01330394)

NCT ID: NCT01330394

Last Updated: 2013-12-24

Results Overview

Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

6 months after treatment

Results posted on

2013-12-24

Participant Flow

35 alcoholic subjects were recruited between October 2012 and January 2013 in diverse public outpatient services specialized in mental health

Participant milestones

Participant milestones
Measure
Sham-tDCS Control
simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
Active tDCS
active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days
Overall Study
STARTED
17
16
Overall Study
COMPLETED
17
16
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Alcoholism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sham-tDCS Control
n=17 Participants
simulate control for transcranial Direct Current Stimulation
Active tDCS
n=16 Participants
active transcranial Direct Current Stimulation
Total
n=33 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=5 Participants
16 Participants
n=7 Participants
33 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
45.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
44.0 years
STANDARD_DEVIATION 7.8 • n=7 Participants
44.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Region of Enrollment
Brazil
17 participants
n=5 Participants
16 participants
n=7 Participants
33 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months after treatment

Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).

Outcome measures

Outcome measures
Measure
Sham-tDCS Control
n=17 Participants
simulate control for transcranial Direct Current Stimulation
Active tDCS
n=16 Participants
active transcranial Direct Current Stimulation
Use of Alcohol
15 participants
8 participants

SECONDARY outcome

Timeframe: one year and a half

Event-related potential (ERPs) was recorded under the presentation of 120 sounds \[60 of 3 types related to the use of alcoholic beverages (open a can of beer, fill a glass of beer, opening and fall of the lid of a bottle of beer), and 3 types of 60 neutral sounds (open a door, typing a keyboard, shower water)\] lasted for 384 s for each period before and after transcranial Direct Current Stimulation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year and a half

Cognitive tests comprised by Frontal Assessment Battery (FAB), verbal n-back task, visuospatial n-back task, go-no-go task, counting Stroop, will be done at the beginning of the session 1 and session 6 (one week after the 5 sessions of sham or tDCS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year and a half

Quality of life scale will be applied at the end of the protocol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year and a half

Obsessive Compulsive Drinking Scale will be applied before and after ERP procedures

Outcome measures

Outcome data not reported

Adverse Events

Sham-tDCS Control

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

Active tDCS

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ester Miyuki Nakamura-Palacios

Federal University of Espírito Santo

Phone: +55 27 7775-7337

Results disclosure agreements

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